Follow-up Protocol for Patients With Cancer/AIDS/Skin Dis... | NCT00001503

Studies
Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease

NCT00001503

Sponsor

National Cancer Institute (NCI)

Status

Completed

Last Update Posted

Jun 18, 2023Actual

Enrollment

1,031Actual

Phase

Not provided

Conditions

Melanoma
Ovarian Cancer
Prostate Cancer
Breast Cancer
Lymphoma

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
96-C-0071

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 19, 1996Actual

Primary Completion Date

Jun 15, 2023Actual

Completion Date

Jun 15, 2023Actual

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Nov 3, 1999

First Posted Date

Nov 4, 1999Estimated

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

Jun 15, 2023

Last Update Posted Date

Jun 18, 2023Actual

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

This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol.

Detailed Description

Background:

Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.
Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigators and the IRB.

Objectives:

-To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol.

Eligibility:

-Patients who were previously enrolled on a CCR protocol and who are not eligible for an active NCI intramural primary research protocol.

Design:

The medical procedures/tests will be based on the patient's diagnosis, treatment and supporting clinical information. This is a follow-up study in which only standard tests and procedures are to be performed.
Clinical information that is relevant to the patients prior protocols will be collected for research purposes.
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

1,031Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1/All Patients		Patients who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol	Provision of a mechanism to follow selected CCR patients when their protocols have been terminated.	30 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

ELIGIBILITY CRITERIA:

Patients of any age who were previously enrolled on a CCR protocol.

Not eligible for or unwilling to participate in an active NCI intramural primary research protocol.

CCR investigator decides it is in the best interests of the patient and the CC for the patient to be seen in follow-up visits at the NIH.

Patient or Legally Authorized Representative (LAR)/guardian is able to provide informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients of any age who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James L Gulley, 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 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
D010051	Ovarian Neoplasms
D011471	Prostatic Neoplasms
D001943	Breast Neoplasms
D008223	Lymphoma
D009369	Neoplasms

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided