Data Collection, Clinical Care and Interventions in CCR, NCI

NCT00923065 | Enrolling By Invitation

• 2 other identifiers: 04016504-C-0165
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study provides cancer care through the National Cancer Institute's Medical Oncology Branch (MOB) to patients who are not enrolled in an active treatment research protocol. Patients receive standard treatments only; no investigational therapies are provided on this protocol. Patients 18 years of age and older may be eligible for this protocol. Candidates are patients for whom an NCI investigator decides that the interests of the patient and the NCI are best served by the patient's enrollment in this protocol to receive care and follow-up within the MOB. This includes patients in the following categories:

• Patients previously enrolled in NCI trials whose participation in this protocol may continue to provide researchers important scientific information
• Patients who will be eligible for a research protocol within the foreseeable future
• Patients whose medical welfare will be seriously compromised by referral back to the community, such as patients with a rare or complex disease for which community resources are inadequate or unavailable
• Terminally ill patients who have received most of their specialized medical care at the Clinical Center and for whom humanitarian considerations dictate that they continue to receive their medical care at NIH after going off study for the remaining weeks or months of life
• Patients with cancer or HIV, or people at risk for cancer or HIV for whom cancer treatments at the NCI are requested through the MOB consult service
• Patients who are participating in a non-treatment NCI research protocol and require standard-of-care therapy
• Patients with cancer or HIV or people at risk for cancer for whom cancer treatment or management at the NCI would add significant value to the institute's cancer training program Participants receive standard medical care, including periodic routine laboratory tests, diagnostic x-rays, and nuclear medicine scans to monitor the course of illness and the effects of any treatment.

Conditions

Neoplasms; Cancer

Keywords

Cancer; Natural History

Outcome Measures

Primary Outcomes (1)

• establishment of data repository for standard of care participants

  Obtain and store information from participants seen for consult, treatment and medical follow-up for NCI patients, other Institute patients and individuals as specified.

  ongoing

Study Arms (4)

Consults

Individuals being seen as a consult.

Donors

Donors of cellular products.

Genetic Follow-Up

Individuals with a known/suspected germline genomic research incidental pathogenic or likely pathogenic variant, and/or who require CLIA confirmation.

Patients

Individuals being enrolled for the treatment or follow-up of their disease.

Eligibility Criteria

• Age: 4 Weeks - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals seen for appropriate clinical care evaluation and procedure, including: consultation, treatment and/or follow-up, cellular donation and/or genetic education, counseling, and CLIA confirmation of a germline research incidental pathogenic or likely pathogenic variant.

You may qualify if:

• Individuals must be age 2 years or older if therapeutic interventions are required. Otherwise, there are no age restrictions beyond the neonatal period (4 weeks).
• Individuals will be eligible if they meet one of the following criteria:
• are seeking a consultation from NCI/CCR.
• whose medical welfare will be seriously compromised by referral back to the community, such as rare/complex diseases in which community treatment is inadequate or adequate community resources are unavailable.
• have cancer, HIV, or are at risk for cancer and/or HIV for whom cancer evaluation, treatment or management at the NCI is requested.
• who will serve or have served as cellular therapy donors, for the treatment of a recipient of cellular therapy on an NCI trial.
• are participants or biologic family members of deceased participants, where genetic testing is required or a clinically actionable germline pathogenic or likely pathogenic variant with medical implications was discovered by a research laboratory that requires CLIA confirmation. Note: In some cases, enrollment onto this study is also necessary when the prior study on which the involved participant was originally enrolled is closed and/or the participant is now off study.
• The individual or their Legally Authorized Representative is able and willing to provide informed consent.

You may not qualify if:

• None

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

Neoplasms

Study Officials

• Fatima H Karzai, 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: June 17, 2009
• First Posted: June 18, 2009
• Study Start: June 10, 2004
• Last Updated: June 1, 2026

Record last verified: 2026-05-11

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)