NCT01441089

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

May 21, 2012

Completed
Last Updated

April 14, 2026

Status Verified

January 23, 2026

First QC Date

September 24, 2011

Last Update Submit

April 11, 2026

Conditions

Keywords

PharmacogeneticsPharmacokineticsPharmacodynamicsClinical OutcomeDrug Metabolism and TransportNatural HistoryCancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

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

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsBreast NeoplasmsLung NeoplasmsOvarian NeoplasmsLymphomaNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleEndocrine System DiseasesGonadal DisordersNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • William D Figg, Pharm.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deneise C Francis, R.N.

CONTACT

William D Figg, Pharm.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2011

First Posted

September 27, 2011

Study Start

May 21, 2012

Last Updated

April 14, 2026

Record last verified: 2026-01-23

Data Sharing

IPD Sharing
Will share

All collected IPD will be shared

Shared Documents
STUDY PROTOCOL, SAP, 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

Locations