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Protocol Details

Data Collection, Clinical Care and Interventions in CCR, NCI

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

04-C-0165

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 4 wk
Max Age: 120 Years

Referral Letter Required

Yes

Population Exclusion(s)

Neonates

Keywords

Cancer;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Neoplasms;
Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

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, 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:

None


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Fatima H. Karzai, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 480-7174
fatima.karzai@nih.gov

Fatima H. Karzai, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 480-7174
fatima.karzai@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT00923065

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