Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00923026
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Background: The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from participants' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow participants to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA. Eligibility: Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol Design Participants will be followed with a physical examination and blood tests for up to 15 years as required by the FDA

Key Dates

Start date
Jun 15, 2009
Status verified
Jan 2026

Study Design

Enrollment
1,150 participants (estimated)

Arms

  • Arm: A/Gene Therapy
    Patients who have received gene therapy
  • Arm: B/Non-Gene Therapy
    Patients who have not received gene therapy

Primary Outcome Measure

Long-term follow-up [ Time Frame: Until time of death ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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