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

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ClinicalTrials.gov Identifier: NCT01441089

Recruitment Status : Recruiting

First Posted : September 27, 2011

Last Update Posted : April 9, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information

First Submitted Date

September 24, 2011

First Posted Date

September 27, 2011

Last Update Posted Date

April 9, 2024

Actual Study Start Date

May 21, 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

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

Official Title

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

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.

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 Type

Observational

Study Design

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition

Prostate Cancer
Breast Cancer
Lung Cancer
Ovarian Cancer
Lymphoma

Intervention

Not Provided

Study Groups/Cohorts

1/ Patients with cancer, other tumors, or possible genetic tumor

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

1100

Original Estimated Enrollment

1000

Study Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

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

Accepts Healthy Volunteers

Contacts

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

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

NCT01441089

Other Study ID Numbers

110242
11-C-0242

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:	Yes
Plan Description:	.All collected IPD will be shared
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	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

Current Responsible Party

National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Original Responsible Party

Not Provided

Current Study Sponsor

National Cancer Institute (NCI)

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:

William D Figg, Pharm.D.

National Cancer Institute (NCI)

PRS Account

National Institutes of Health Clinical Center (CC)

Verification Date

April 3, 2024

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