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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:

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

James L. Gulley, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240C
10 CENTER DR
BETHESDA MD 20892
(301) 480-7164
gulleyj@mail.nih.gov

James L. Gulley, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240C
10 CENTER DR
BETHESDA MD 20892
(301) 480-7164
gulleyj@mail.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

Clinical Trials Number:

NCT00923065

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