Clinical trial NCT00923026: Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Official title: Follow-Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Melanoma
Adenocarcinoma
Carcinoma NOS
Neuroendocrine Tumors
Keywords: Gene Therapy
Follow-Up
Delayed Toxicity
Natural History
Adenocarcinoma
Melanoma
Neuroendocrine Tumors
Carcinoma
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2009-06-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will have previously been enrolled on an NCI Surgery Branch treatment protocol. Patients who received gene therapy will be followed as required by the FDA.

Brief 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

Detailed description: Background:

* Patients receiving care at the NIH Clinical Center are required to be enrolled on a clinical protocol.
* Following participation in a treatment protocol, it may be in the best interest of the patient to continue to be followed at the Clinical Center.
* The National Cancer Institute Surgery Branch (NCI-SB) conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (FDA) requirements for long-term follow-up are up to fifteen years for some products. As this time-period is frequently longer than studies are expected to be open, a long-term follow-up protocol is necessary to ensure the follow-up of these participants.

Objective:

-Primary objective:

--Provide a mechanism for long-term follow-up of participants who have participated in research studies in the NCI-SB.

Eligibility:

* Age greater than or equal to 18 years.
* Participant has been enrolled on an NCI-SB treatment protocol.

Design:

* Participant will undergo physical exams, laboratory evaluation, imaging, or phone follow-up as clinically indicated.
* Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.

Eligibility criteria: * INCLUSION CRITERIA:
* 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.

EXCLUSION CRITERIA:

-For Cohort B: Individuals of child-bearing potential (IOCBP) who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.

Primary outcomes:
measure: Long-term follow-up
timeFrame: Until time of death
Secondary outcomes:
measure: Long-term follow-up for gene therapy studies
timeFrame: 15 years
measure: Survival
timeFrame: Until time of death
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Steven A Rosenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: