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Protocol Details

Collection of Blood, Fluid, Bone Marrow, Tumor, or Tissue Samples from Patients with Cancer or Normal Volunteers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

00-C-0078

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children;
Fetuses;
Neonates;
Pregnant Women

Keywords

Assays;
Resistance;
Biopsy Samples;
Specimen Acquisition;
Cancer Cells;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Renal Cell Carcinoma;
Lung carcinoma;
Cervical Carcinoma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

This study will examine blood, bone marrow, tumor and tissue samples from patients with cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer improve initially with chemotherapy, but then have a disease relapse, after which their tumor no longer responds to treatment. Other patients tumors are drug-resistant from the start. The study will look for "resistance factors"-substances in blood and tissues that render tumors resistant to chemotherapy. The findings may provide information needed to develop methods of combating drug resistance.

Patients with cancer who are 18 years or older may be eligible for this study. Participants will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study; additional samples will be obtained periodically during the course of treatment. A small sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor biopsy (removal of a small piece of tumor) for medical reasons or as part of a research treatment protocol. Patients who do not require surgery or biopsy may be asked permission to obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1) withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen; 3) removing a small tumor sample through a needle; or 4) removing the sample with a small incision into or around the tumor. These procedures will be done only if they are of low risk to the patient.

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Eligibility

INCLUSION CRITERIA:

1. Participants 18 years of age and older are eligible.

2. Participants must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.

3. Participants with malignancy are eligible.

4. Participants requiring a surgical procedure for any medical indication can be included on study.

5. Participants requiring biopsy or any procedure for any medical indication can be included on study.

6. Participants not requiring biopsy for a medical indication can be included on the study solely for the purpose of obtaining research samples, including blood, pleural fluid, or peritoneal fluid, or biopsy samples. No radiology tests will be used in the procedure to collect a sample that would not be otherwise used for an appropriate medical indication.

7. Normal volunteers 18 years of age and older are eligible to enroll. Normal volunteers must be willing to sign informed consent and must be willing to provide samples to be used for research.

EXCLUSION CRITERIA:

1. Pregnant individuals will not be eligible due to potential risks to the fetus associated with radiologic procedures required for biopsy.

2. Children will not be eligible because of potential risks from complications due to procedures involved in obtaining the biopsies.

3. Normal volunteers with a history of a clotting disorder may not enroll.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

William D. Figg, Pharm.D.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 5A01
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6179
figgw@mail.nih.gov

Deneise Francis, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N222
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3974
deneise.francis@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:

NCT00026663

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