Data Collection, Clinical Care and Interventions in CCR, NCI
NCT ID: NCT00923065
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
10000 participants
OBSERVATIONAL
2004-06-10
Brief Summary
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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.
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Detailed Description
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* Clinical Investigators within the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) evaluate and treat patients with cancer, HIV, and individuals at risk for developing cancer in the context of active research protocols.
* In some cases, it may be in the best interests of both the individual and the CCR to provide consult services, treatment/interventions, and/or follow-up to certain individuals and collect the data obtained for future research.
Objectives:
-To provide a repository of information on enrolled participants to allow for hypothesis generation in future research
Eligibility:
* To allow a mechanism to provide consult, treatment, and medical follow-up for patients, including genetic education and counseling as well as cell/marrow donors to NCI patients and other individuals needed to be seen within the CCR.
* It is in the best interests of the individual and the CCR for the individual to receive a consultation or other medical evaluation, treatment, or follow-up, or to donate cellular products at the NCI, NIH Intramural Research Program.
Design:
* This protocol will provide the administrative vehicle for NCI investigators to provide consult services to individuals.
* Medical/surgical/radiotherapeutic care, treatment, and follow-up may be provided for certain participants.
* No investigational therapies will be administered on this study.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Consults
Individuals being seen as a consult.
No interventions assigned to this group
Donors
Donors of cellular products.
No interventions assigned to this group
Genetic Follow-Up
Individuals with a known/suspected germline genomic research incidental pathogenic or likely pathogenic variant, and/or who require CLIA confirmation.
No interventions assigned to this group
Patients
Individuals being enrolled for the treatment or follow-up of their disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
4 Weeks
120 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Fatima H Karzai, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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040165
Identifier Type: -
Identifier Source: org_study_id
NCT00898625
Identifier Type: -
Identifier Source: nct_alias
04-C-0165
Identifier Type: -
Identifier Source: secondary_id