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

NCT00001503 | Completed

• 2 other identifiers: 96007196-C-0071
• Study Type: observational
• Target: 1,031
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Ovarian Cancer; Prostate Cancer; Breast Cancer; Lymphoma

Keywords

Cancer; Late-effects; Survival; Follow-Up; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1/All Patients

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

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Melanoma; Ovarian Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Lymphoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• James L Gulley, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: September 19, 1996
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)