Data Collection, Clinical Care and Interventions in CCR, NCI

Cancer Clinical Trial

Official title:

Data Collection, Clinical Care and Interventions in CCR, NCI

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00923065
• Other study ID #: 040165
• Secondary ID: 04-C-0165
• Status: Enrolling by invitation
• Start date: June 10, 2004

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00898625

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Weeks to 120 Years

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

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NIH Clinical Center Detailed Web Page