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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01441089
• Other study ID #: 110242
• Secondary ID: 11-C-0242
• Status: Recruiting
• Start date: May 21, 2012

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Deneise Francis, R.N.
• Phone: (240) 858-3974
• Email: deneise.francis[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Disease Susceptibility
• Lung Cancer
• Lymphoma
• Ovarian Cancer
• Prostate Cancer

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   NIH Clinical Center Detailed Web Page