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Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes 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.
 
ClinicalTrials.gov Identifier: NCT01441089
Recruitment Status : Recruiting
First Posted : September 27, 2011
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
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Brief Summary:

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.

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

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 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.

Objectives:

  • To obtain and analyze the genomic DNA from patients with cancer, other tumors, and tumor predisposition syndromes 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.

Eligibility:

-All individuals enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials.

Design:

  • Exploratory study with a planned accrual of 1,100 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 Pharmacoscan platform (Thermo).
  • 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, other tumors, and tumor predisposition syndromes often receive multiple agents to manage side effects and co-morbidities.
  • The association between variants in Pharmacoscan-covered genes will be correlated with PK/PD and clinical outcomes such as response and/or toxicity.
Study Design
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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Analysis of Genetic Differences in Drug Disposition
Actual Study Start Date : May 21, 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, 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 with cancer, other tumors, or possible genetic tumor predisposition syndromes.
Criteria
  • INCLUSION CRITERIA:

Patients with cancer, other tumors, or tumor predisposition syndromes currently enrolled in NIH intramural research program therapeutic trials.

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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01441089


Contacts
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Contact: Deneise Francis, R.N. (240) 858-3974 deneise.francis@nih.gov
Contact: William D Figg, Pharm.D. (240) 760-6179 figgw@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)
More Information
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Additional Information:

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01441089    
Other Study ID Numbers: 110242
11-C-0242
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 3, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All collected IPD will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data from this study may be requested from other researchers after the completion of the primary endpoint.
Access Criteria: Data from this study may be requested by contacting the PI

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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) ):
Pharmacogenetics
Pharmacokinetics
Pharmacodynamics
Clinical Outcome
 Drug Metabolism and Transport
Natural History
Cancer
Additional relevant MeSH terms:
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Disease Susceptibility
Disease Attributes
Pathologic Processes