Data Collection, Clinical Care and Interventions in CCR, NCI

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.

...

Study Overview

• Status: Enrolling by invitation
• Conditions: Neoplasms; Cancer

Detailed Description

Background:

It may be in the interest of the Center for Cancer Research (CCR) to evaluate, provide treatment/interventions and/or follow certain eligible individuals.

Objective:

The objective of this protocol is to add value to the medical or surgical oncology training programs by providing consult, treatment and medical follow-up for NCI patients, donors to NCI patients and other Institute patients and individuals, as specified.

Eligibility:

It is in the best interests of the individual and the CCR for the individual to receive a medical evaluation, treatment, or follow-up, or to donate cellular products at the NCI, NIH Intramural Research Program.

Design:

No investigational therapies will be administered on this study.

This protocol will provide the administrative vehicle to provide cancer care for individuals in the intramural research program.

This protocol will provide the administrative vehicle for NCI investigators to provide consult services to individuals.

Medical/surgical/radiotherapeutic care, treatment and follow-up is provided for eligible individuals.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

• INCLUSION CRITERIA:

Participant must be age 2 or older if therapeutic interventions are required. Otherwise, there are no age restrictions beyond the neonatal period (4 weeks).

A CCR investigator decides that it is in the best interest of the patient/individual and the CCR for the individual to receive consult, treatment and/or follow-up, including genetic follow-up, at the NCI/NIH.

OR

Related cell therapy donors/potential donors for individuals being considered for or are eligible for transplant on an NCI trial

OR

Related cell therapy donors for patients previously transplanted on an NCI trial who require non-investigational diagnostic studies and/or therapies for transplant-related complications that arise urgently and/or are unable to be addressed on an existing NIH treatment protocol or by providers outside the NIH.

The individual or their Legally Authorized Representative is able and willing to provide informed consent

EXCLUSION CRITERIA:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: James L Gulley, M.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2004

Study Registration Dates

• First Submitted: June 17, 2009
• First Submitted That Met QC Criteria: June 17, 2009
• First Posted (Estimated): June 18, 2009

Study Record Updates

• Last Update Posted (Estimated): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 8, 2024

More Information

Terms related to this study

• Keywords: Cancer; Natural History
• Other Study ID Numbers: 040165; 04-C-0165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data available during the study and indefinitely.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No