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

Status: Enrolling_by_invitation
Location: See location...
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age greater than or equal to 18 years.

• Participants who have received treatment on an NCI-SB protocol, including gene therapy protocols. (Note: Participants may be enrolled on this protocol and, at the same time, participate in an active treatment study).

• For Cohort A:Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. For Cohort B: Participant is able to provide informed consent.

Locations
United States
Maryland
National Institutes of Health Clinical Center
Bethesda
Time Frame
Start Date: 2009-06-15
Participants
Target number of participants: 1150
Treatments
A/Gene Therapy
Patients who have received gene therapy
B/Non-Gene Therapy
Patients who have not received gene therapy
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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