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Collection of Blood From Cancer Patients for Genetic Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01441089
Recruitment Status : Recruiting
First Posted : September 27, 2011
Last Update Posted : May 25, 2021
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- 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.


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


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


  • 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.

Condition or disease
Prostate Cancer Breast Cancer Lung Cancer Ovarian Cancer Lymphoma

Detailed Description:


  • 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 cancer chemotherapy are especially important given the narrow therapeutic index of these drugs.
  • During analysis of investigational agents, inter-individual variation in pharmacokinetics and pharmacodynamics (PK/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.


  • To obtain and analyze the genomic DNA from patients with cancer on a therapeutic clinical trial.
  • To prospectively explore correlations between genetic variants involved in inter-individual differences in drug disposition versus pharmacokinetics, pharmacodynamics, response, and toxicity endpoints in patients receiving pharmaceutical agents.
  • To mitigate harm due to treatment with ineffective or toxicity-inducing drugs in patients where gene-drug interactions are established.


- All individuals enrolled on IRB approved therapeutic clinical trials at the National Cancer Institute.


  • Exploratory study with a planned accrual of 1,000 patients
  • Genomic DNA will be extracted from blood samples collected from patients (patients with leukemia will have cheek swab samples collected) and genotyped using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET).
  • In cases where patients carry genetic variants that are 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. This will apply to non-anticancer agents as well given that patients with cancer often receive multiple agents to manage side effects and co-morbidities.
  • The association between genetic variants in DMET-covered genes will be correlated with PK/PD and clinical outcomes such as response and/or toxicity.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Collection of Blood From Patients With Cancer for Analysis of Genetic Differences in Drug Disposition
Actual Study Start Date : May 21, 2012

1/Cancer Patients
Patients enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials

Primary Outcome Measures :
  1. Obtain and analyze the genomic DNA from patients with cancer 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Cancer patients currently enrolled in a Medical Oncology Branch IRB approved therapeutic trials at the National Cancer Institute are eligible.

Ability of patient or Legally Authorized Representative (LAR) to understand and be willing to sign the informed consent document.

Must be greater than or equal to 18.


Not applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01441089

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Contact: Deneise Francis (240) 858-3974
Contact: William D Figg, Pharm.D. (240) 760-6179

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT01441089    
Other Study ID Numbers: 110242
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: March 19, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Clinical Outcome
Drug Metabolism and Transport