Clinical trial NCT06194461: LTFU for All Cell and Gene Therapy Studies
Official title: A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Prostate Cancer
Keywords: Cell Therapy
Gene Therapy
Long term follow up
LTFU
Hepatocellular carcinoma
Prostate cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-01-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been treated with Cell/Gene therapy products in AstraZeneca clinical trials.

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.

Detailed description: This is a multi-centre and multinational basket study that will monitor the long-term safety and tolerability of cell or gene therapies in participants that have taken part in other AstraZeneca cell or gene therapy studies for up to 15 years.

Eligibility criteria: 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.

Exclusion Criteria:

Not applicable

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Primary outcomes:
measure: Incidence of specific AEs
timeFrame: Maximum of 15 years post dosing
Secondary outcomes:
measure: Disease progression status and Overall survival
timeFrame: Maximum of 15 years post dosing.
measure: Kinetics parameters that indicate persistence (eg, Clast and Tlast)
timeFrame: Maximum of 15 years post dosing
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Duarte
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Westwood
country: United States
facility: Research Site
state: Kansas
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Houston
country: United States
facility: Research Site
state: Texas
city: East Melbourne
country: Australia
facility: Research Site
city: Kashiwa
country: Japan
facility: Research Site
city: Osakasayama-shi
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
References: