Follow Up Protocol for Subjects Previously Enrolled on NC... | NCT00923026

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

NCT00923026

Sponsor

National Cancer Institute (NCI)

Status

Enrolling by invitation

Last Update Posted

Jul 2, 2026Actual

Enrollment

1,150Estimated

Phase

Not provided

Conditions

Melanoma
Adenocarcinoma
Carcinoma NOS
Neuroendocrine Tumors

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
09-C-0161

Status Module

Record Verification Date

Jan 22, 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2009Actual

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 17, 2009

First Submission Date that Met QC Criteria

Jun 17, 2009

First Posted Date

Jun 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A/Gene Therapy		Patients who have received gene therapy
B/Non-Gene Therapy		Patients who have not received gene therapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Survival

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steven A Rosenberg, M.D.	National Cancer Institute (NCI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center		Bethesda	Maryland	20892	United States

Label	URL
NIH Clinical Center Detailed Web Page	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD recorded in the medical record will be shared with intramural investigators upon request.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Clinical data will be available during the study and indefinitely.

Access Criteria

Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D000230	Adenocarcinoma
D002277	Carcinoma
D018358	Neuroendocrine Tumors

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided