Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance

NCT00026663 | Completed

• 2 other identifiers: 00007800-C-0078
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Cell Carcinoma; Lung Carcinoma; Cervical Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To obtain specimens to develop assays

  Obtain sufficient number of samples for a given test.

  End of study

Study Arms (2)

1/Patients with cancer

Cancer patients providing tissue for research studies

2/Normal Volunteers

normal volunteers providing samples for research studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignancy requiring a surgical procedure or biopsy for any medical indication. Healthy volunteers not requiring biopsy for a medical indication.

You may qualify if:

• Participants 18 years of age and older are eligible.
• Participants must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
• Participants with malignancy are eligible.
• Participants requiring a surgical procedure for any medical indication can be included on study.
• Participants requiring biopsy or any procedure for any medical indication can be included on study.
• 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.
• 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.

You may not qualify if:

• Pregnant individuals will not be eligible due to potential risks to the fetus associated with radiologic procedures required for biopsy.
• Children will not be eligible because of potential risks from complications due to procedures involved in obtaining the biopsies.
• Normal volunteers with a history of a clotting disorder may not enroll.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Carcinoma, Renal Cell; Lung Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Study Officials

• William D Figg, Pharm.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2001
• First Posted: November 15, 2001
• Study Start: August 9, 2000
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)