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Enrolling by invitationNCT00923065Updated Nov 6, 2026

Data Collection, Clinical Care and Interventions in CCR, NCI

An observational study in Neoplasms and Cancer, sponsored by National Cancer Institute (NCI). Enrolling by invitation at 1 site in United States. Open to participants aged 4 Weeks to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
4 Weeks to 120 Years
Sex
All
01

Study 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.

Read the detailed description

Background:

  • 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.
02

Conditions studied

  • Neoplasms
  • Cancer

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Keywords

  • Cancer
  • Natural History
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Weeks to 120 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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, , 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 .

Exclusion criteria

EXCLUSION CRITERIA:

None

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: ongoing

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

Individual participant data

Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Updates

4 registry updates since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: description and verification date
4 updates, last Nov 6, 2026
Show all 4 updates
  1. Nov 6, 2026
    Minor edits only
    + 1 other change: verification date
  2. Nov 3, 2026
    Minor edits only
    + 1 other change: verification date
  3. Oct 16, 2026
    Minor edits only
    + 1 other change: description
  4. Oct 8, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00923065
Responsible party
Sponsor
First posted
Jun 18, 2009
Start date
Jun 10, 2004
Last update
Nov 6, 2026

Study contacts

Fatima H Karzai, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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