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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00923026
• Other study ID #: 090161
• Secondary ID: 09-C-0161
• Status: Enrolling by invitation
• Start date: June 15, 2009

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

INCLUSION CRITERIA:

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma NOS
• Melanoma
• Neuroendocrine Tumors

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term follow-up	Long-term follow-up of subjects who have participated in research studies in the NCI Surgery Branch	Until time of death
Secondary	Long-term follow-up for gene therapy studies	Collection of long-term, follow-up information on subjects who have participated in gene transfer studies as required by the FDA and other regulatory groups	15 years
Secondary	Survival	Follow subjects who have participated in research studies in the NCI Surgery Branch until time of death	Until time of death

External Links

•   NIH Clinical Center Detailed Web Page