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

Collection of Blood, Fluid, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer or Normal Volunteers

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Cell Carcinoma; Cervical Carcinoma; Lung Carcinoma

Detailed Description

Background:

Ongoing research in the Molecular Pharmacology Section, NCI, requires the availability of blood, fluid, bone marrow, tumor, hair follicle and tissue samples from patients with cancer. Resistance is the underlying cause of treatment failure, and may present as acquired or intrinsic drug resistance. Patients with cancer frequently present with chemotherapy-responsive disease, and undergo tumor response, only to eventually experience relapse, at which time the tumor may be refractory to further treatment. This is termed acquired drug resistance; while intrinsic resistance implies a cancer that is refractory from the outset. Diverse mechanisms of drug resistance have been described and are often dependent upon the particular drug under study.

Objectives:

To obtain blood, fluid, hair follicles, bone marrow, tumor and/or normal tissue samples that would allow development of assays for use in subsequent clinical trials.

Eligibility:

Patients with a prior diagnosis of malignancy, with advanced or refractory cancer will be evaluated in the GMB Clinic, NCI.

Participants may be on, or in the process of being evaluated for a research protocol. Participants may receive treatment on the standard care protocol.

Normal volunteers may enroll in the study.

Design:

Acquired samples will be recorded in the computerized data bank currently existing in the Molecular Pharmacology Section. No germline testing will be performed on any of the samples collected. Tests will be pilot studies relating to the Section s work on the biology of drug resistance and cell survival in cancer.

Sample collection for patients with cancer:

• Blood samples, fluid samples, or hair follicle samples may be collected at the initial visit, and at follow up visits.
• Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, or by excisional biopsy, providing the tumor is accessible.
• Bone marrow aspirate, thoracentesis, and paracentesis may be performed.

Normal volunteers may enroll in the study for collection of blood, fluid, and/or hair follicle samples.

Examples of the types of studies to be performed with biopsies will be drug resistance gene expression assays, with the goal of demonstrating the utility of the assay in participant samples.

Evaluation of methods to detect drug resistance proteins and genes will be explored, including Northern blot, immunoblot, polymerase chain reaction assay, and RNA in situ hybridization. With whole blood, we may evaluate the presence of dye transport in an ex vivo assay, for example, using inhibitors of ABCG2. Evidence of drug accumulation or DNA damage may be sought in participant mononuclear cells or in hair follicle samples.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: William D Figg, Pharm.D.; Phone Number: (240) 760-6179; Email: figgw@mail.nih.gov
• Study Contact Backup: Name: Deneise Francis, R.N.; Phone Number: (240) 858-3974; Email: deneise.francis@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1/Patients with cancer; Cancer patients providing tissue for research studies
2/Normal Volunteers; normal volunteers providing samples for research studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To obtain specimens to develop assays	Obtain sufficient number of samples for a given test.	End of study

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: William D Figg, Pharm.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2000

Study Registration Dates

• First Submitted: November 14, 2001
• First Submitted That Met QC Criteria: November 14, 2001
• First Posted (Estimated): November 15, 2001

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: October 3, 2023

More Information

Terms related to this study

• Keywords: Natural History; Resistance; Assays; Biopsy Samples; Specimen Acquisition; Cancer Cells
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: 000078; 00-C-0078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data available during the study and indefinitely.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No