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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04889924
Registration number
NCT04889924
Ethics application status
Date submitted
5/05/2021
Date registered
17/05/2021
Date last updated
4/07/2025
Titles & IDs
Public title
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
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Scientific title
Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
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Secondary ID [1]
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PR148/21
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Universal Trial Number (UTN)
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Trial acronym
ADARNAT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Chemotherapy
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Sentinel Lymph Node
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Axillary Lymph Nodes Dissection
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Radiotherapy Side Effect
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Axillary Radiotherapy
Treatment: Surgery - Lymphadenectomy
Experimental: Axillary radiotherapy without lymphadenectomy - Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
Active comparator: Axillary lymph node dissection - Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
Treatment: Other: Axillary Radiotherapy
Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
Treatment: Surgery: Lymphadenectomy
Axillary Lymph node dissection
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-free survival
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Assessment method [1]
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To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.
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Timepoint [1]
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From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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To assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.
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Timepoint [1]
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From date of diagnosis until the date of death from any cause, assessed up to 5 years
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Secondary outcome [2]
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Lymphedema Incidence
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Assessment method [2]
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Volume difference between both arms (cm\^3) above 10%
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Timepoint [2]
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From date of surgery until the date of first lynphedema apparition, assessed up to 3 years
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Eligibility
Key inclusion criteria
* T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment
* Post-CT SLN with =2 macrometastasis/micrometastasis or ITCs
* Post-CT axillary response by ultrasound or MRI
* Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* cN2
* ypN0
* History of breast surgery for ipsilateral cancer in the last 10 years
* History of other cancer in the last 5 years, except squamous carcinoma of the skin.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
1660
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GenesisCare Mater - Sydney
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Recruitment hospital [2]
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GenesisCare North Shore - Sydney
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Recruitment hospital [3]
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GenesisCare Frenchs Forest - Sydney
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Recruitment hospital [4]
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GenesisCare Norwest - Sydney
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Recruitment hospital [5]
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GenesisCare Hurstville - Sydney
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Recruitment hospital [6]
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GenesisCare Campbelltown - Sydney
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Recruitment postcode(s) [1]
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2060 - Sydney
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Recruitment postcode(s) [2]
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2065 - Sydney
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Recruitment postcode(s) [3]
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2086 - Sydney
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Recruitment postcode(s) [4]
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2153 - Sydney
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Recruitment postcode(s) [5]
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2220 - Sydney
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Recruitment postcode(s) [6]
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2560 - Sydney
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Recruitment outside Australia
Country [1]
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Spain
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State/province [1]
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Barcelona
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Country [2]
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Spain
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State/province [2]
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Bizkaia
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Spain
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State/province [3]
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Cádiz
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Country [4]
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Spain
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State/province [4]
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Gipuzkoa
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Country [5]
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Spain
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State/province [5]
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Madrid
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Country [6]
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Spain
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State/province [6]
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Murcia
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Country [7]
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Spain
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State/province [7]
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Pontevedra
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Country [8]
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Spain
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State/province [8]
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Santa Cruz De Tenerife
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Country [9]
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Spain
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State/province [9]
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Tarragona
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Country [10]
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Spain
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State/province [10]
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A Coruña
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Country [11]
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Spain
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State/province [11]
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Burgos
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Country [12]
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Spain
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State/province [12]
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Girona
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Country [13]
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Spain
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State/province [13]
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Granada
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Country [14]
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Spain
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State/province [14]
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Málaga
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Country [15]
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Spain
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State/province [15]
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Pamplona
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Country [16]
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Spain
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State/province [16]
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Segovia
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Country [17]
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Spain
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State/province [17]
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Sevilla
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Country [18]
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Spain
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State/province [18]
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Valencia
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Country [19]
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Spain
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State/province [19]
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Valladolid
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Country [20]
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Spain
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State/province [20]
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Álava
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Funding & Sponsors
Primary sponsor type
Other
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Name
Hospital Universitari de Bellvitge
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.
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Trial website
https://clinicaltrials.gov/study/NCT04889924
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Maria Laplana, MDPhD
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Address
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Hospital Clínico y Provincial de Barcelona
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amparo Garcia-Tejedor, MDPhD
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Address
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Country
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Phone
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34 + 932607695
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04889924
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