Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis

April 11, 2026 updated by: National Cancer Institute (NCI)

Collection of Blood From Therapeutic Trial Participants for Analysis of Genetic Differences in Drug Disposition and Pharmacokinetics of Probe Medications

Background:

- Some genes may be associated with a greater chance of side effects during cancer treatment. These genes may also make certain treatments less effective. Researchers want to collect blood or cheek swab samples from people having cancer treatment to study these genes.

Objectives:

- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer treatment.

Eligibility:

- Individuals with cancer who are being treated at the National Cancer Institute.

Design:

  • Participants will provide a blood sample for study.
  • Participants who have blood-based cancer, such as leukemia, will provide a cheek swab sample.
  • If the blood or cheek swab sample does not have enough genetic material for analysis, an additional sample may be collected.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background:

  • Genetic polymorphisms in drug-metabolizing enzymes, transporters/receptors might affect an individual's response to drug therapy.
  • Inter-individual differences in efficacy and toxicity of antitumor agents are especially important given the narrow therapeutic index of these drugs.
  • During analysis of investigational agents, inter-individual variation in pharmacokinetics (PK) and pharmacodynamics (PD) is most often noted. Genetic variation in genes encoding proteins that regulate or mediate the metabolism and transport of drugs often account for some of the wide variation seen in PK/PD, and ultimately the response to, and toxicity from, pharmaceutical agents.
  • The administration of probe substrates can be used to determine the phenotype of enzymes and transporters responsible for drug disposition, providing a useful tool to better understand the cause of unexpected AEs or toxicities of clinical trial participants.

Objectives:

-Explore potential associations between genetic variants discovered with Pharmacoscan involved in inter-individual differences in drug disposition versus the pharmacokinetics, pharmacodynamics of pharmaceutical agents.

Eligibility:

-Any individual currently enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials.

Design:

  • Exploratory study with a planned accrual of 1,100 participants.
  • Genomic DNA extracted from blood samples collected from participants (participants with leukemia will have cheek swab samples collected) will be analyzed.
  • In cases where participants carry genetic variants that related to poor outcome or significant toxicity on a given drug, clinical recommendations will be provided where specific instructions are available in the package insert.
  • The association between variants in Pharmacoscan-covered genes will be correlated with PK/PD and clinical outcomes such as response and/or toxicity.
  • Genotyping and/or phenotyping probe administration will be used to identify potential genetic variants with unknown or poorly defined drug interactions, including genetic variants with unknown metabolic phenotype and drugs with poorly defined metabolic pathways in the literature.
  • The Clinical Pharmacology Program (CPP) will measure the plasma concentration of enzyme or transporter phenotyping probe substrates (or send the sample out to a third party if the assay is commercially available) in select participants enrolled on clinical trials at the CCR.

Study Type

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center
        • Contact:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Phone Number: TTY dial 711 800-411-1222
          • Email: ccopr@nih.gov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patient enrolled on an IRB approved NIH Intramural Research Program therapeutic clinical trial with cancer, other tumors, or possible genetic tumor predisposition syndromes.

Description

  • INCLUSION CRITERIA:
  • Any individual currently enrolled in an NIH intramural research program clinical trials receiving treatment.
  • Ability of participant or Legally Authorized Representative (LAR) to understand and be willing to sign the informed consent document.
  • Age >= 3 years old

EXCLUSION CRITERIA:

-N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1/ Patients with cancer, other tumors, or possible genetic tumor
Patients enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obtain and analyze the genomic DNA from patients with cancer, other tumors, or possible genetic tumor predisposition syndromes on a therapeutic clinical trial.
Time Frame: duration of study
to determine the association between SNP parameters and clinical response and/or toxicity from genomic DNA extracted from patient samples
duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2012

Study Registration Dates

First Submitted

September 24, 2011

First Submitted That Met QC Criteria

September 24, 2011

First Posted (Estimated)

September 27, 2011

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

January 23, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110242
  • 11-C-0242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD will be shared

IPD Sharing Time Frame

Data from this study may be requested from other researchers after the completion of the primary endpoint.

IPD Sharing Access Criteria

Data from this study may be requested by contacting the 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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