Prostate CancerNCT01441089
Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis
An observational study of Prostate Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Lung Cancer
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2012to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Collection of Blood From Therapeutic Trial Participants for Analysis of Genetic Differences in Drug Disposition and Pharmacokinetics of Probe Medications
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.
Read more
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.
Read the 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 (PK) and pharmacodynamics (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.
- The administration of probe substrates can be used to determine the phenotype of enzymes and transporters responsible for drug disposition, providing a useful tool to better understand the cause of unexpected AEs or toxicities of clinical trial participants.
Objectives:
-Explore potential associations between genetic variants discovered with Pharmacoscan involved in inter-individual differences in drug disposition versus the pharmacokinetics, pharmacodynamics of pharmaceutical agents.
Eligibility:
-Any individual currently enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials.
Design:
- Exploratory study with a planned accrual of 1,100 participants.
- Genomic DNA extracted from blood samples collected from participants (participants with leukemia will have cheek swab samples collected) will be analyzed.
- In cases where participants carry genetic variants that 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.
- The association between variants in Pharmacoscan-covered genes will be correlated with PK/PD and clinical outcomes such as response and/or toxicity.
- Genotyping and/or phenotyping probe administration will be used to identify potential genetic variants with unknown or poorly defined drug interactions, including genetic variants with unknown metabolic phenotype and drugs with poorly defined metabolic pathways in the literature.
- The Clinical Pharmacology Program (CPP) will measure the plasma concentration of enzyme or transporter phenotyping probe substrates (or send the sample out to a third party if the assay is commercially available) in select participants enrolled on clinical trials at the CCR.
- Conditions
- Prostate Cancer, Breast Cancer, Lung Cancer, Ovarian Cancer, Lymphoma
- Keywords
- Pharmacogenetics, Pharmacokinetics, Pharmacodynamics, Clinical Outcome, Drug Metabolism and Transport, Natural History, Cancer
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Lymphoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/ Patients with cancer, other tumors, or possible genetic tumor | Patients enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study start21 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William D Figg, Pharm.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441089
- Sponsor's protocol ID
- 110242
- Other IDs
- 11-C-0242
- Status last verified
- 23 Jan 2026
- First submitted
- 24 Sep 2011
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood From Therapeutic Trial Participants for Analysis of Genetic Differences in Drug Disposition and Pharmacokinetics of Probe Medications
- ClinicalTrials.gov ID
- NCT01441089
- Acronym / sponsor ID
- 110242
- Conditions
- Prostate Cancer, Breast Cancer, Lung Cancer, Ovarian Cancer, Lymphoma
- Keywords
- Pharmacogenetics, Pharmacokinetics, Pharmacodynamics, Clinical Outcome, Drug Metabolism and Transport, Natural History, Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 May 2012 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (PK) and pharmacodynamics (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.
- The administration of probe substrates can be used to determine the phenotype of enzymes and transporters responsible for drug disposition, providing a useful tool to better understand the cause of unexpected AEs or toxicities of clinical trial participants.
Objectives:
-Explore potential associations between genetic variants discovered with Pharmacoscan involved in inter-individual differences in drug disposition versus the pharmacokinetics, pharmacodynamics of pharmaceutical agents.
Eligibility:
-Any individual currently enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials.
Design:
- Exploratory study with a planned accrual of 1,100 participants.
- Genomic DNA extracted from blood samples collected from participants (participants with leukemia will have cheek swab samples collected) will be analyzed.
- In cases where participants carry genetic variants that 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.
- The association between variants in Pharmacoscan-covered genes will be correlated with PK/PD and clinical outcomes such as response and/or toxicity.
- Genotyping and/or phenotyping probe administration will be used to identify potential genetic variants with unknown or poorly defined drug interactions, including genetic variants with unknown metabolic phenotype and drugs with poorly defined metabolic pathways in the literature.
- The Clinical Pharmacology Program (CPP) will measure the plasma concentration of enzyme or transporter phenotyping probe substrates (or send the sample out to a third party if the assay is commercially available) in select participants enrolled on clinical trials at the CCR.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/ Patients with cancer, other tumors, or possible genetic tumor | – | –Patients enrolled on IRB approved NIH Intramural Research Program (IRP) therapeutic clinical trials |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William D Figg, Pharm.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deneise C Francis, R.N. ((240) 858-3974, deneise.francis@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.