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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06194461




Registration number
NCT06194461
Ethics application status
Date submitted
7/12/2023
Date registered
8/01/2024
Date last updated
5/07/2024

Titles & IDs
Public title
LTFU for All Cell and Gene Therapy Studies
Scientific title
A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
Secondary ID [1] 0 0
D9341C00001
Universal Trial Number (UTN)
Trial acronym
LOCUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - AZD5851
Treatment: Other - AZD0754

AZD5851 - Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884

AZD0754 - Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729


Treatment: Other: AZD5851
Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884.

Treatment: Other: AZD0754
Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of specific AEs
Timepoint [1] 0 0
Maximum of 15 years post dosing
Secondary outcome [1] 0 0
Disease progression status and Overall survival
Timepoint [1] 0 0
Maximum of 15 years post dosing.
Secondary outcome [2] 0 0
Kinetics parameters that indicate persistence (eg, Clast and Tlast)
Timepoint [2] 0 0
Maximum of 15 years post dosing

Eligibility
Key inclusion criteria
1. The participant has received a cell or gene therapy in another AstraZeneca protocol.
2. Provision of signed and dated, written informed consent before any study-specific procedures.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not applicable

-

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
16/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/11/2041
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Master LTFU study will monitor the long-term safety and tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment.
Trial website
https://clinicaltrials.gov/study/NCT06194461
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06194461