Renal Cell CarcinomaNCT00026663
Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance
An observational study of Renal Cell Carcinoma and Lung Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will examine blood, bone marrow, tumor and tissue samples from patients with cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer improve initially with chemotherapy, but then have a disease relapse, after which their tumor no longer responds to treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Cell Carcinoma, Lung Carcinoma, Cervical Carcinoma
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2000to 28 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with malignancy requiring a surgical procedure or biopsy for any medical indication. Healthy volunteers not requiring biopsy for a medical indication.
Who may be able to join
- Participants 18 years of age and older are eligible.
- Participants must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
- Participants with malignancy are eligible.
- Participants requiring a surgical procedure for any medical indication can be included on study.
- Participants requiring biopsy or any procedure for any medical indication can be included on study.
- Participants not requiring biopsy for a medical indication can be included on the study solely for the purpose of obtaining research samples, including blood, pleural fluid, or peritoneal fluid, or biopsy samples. No radiology tests will be used in the procedure to collect a sample that would not be otherwise used for an appropriate medical indication.
- Normal volunteers 18 years of age and older are eligible to enroll. Normal volunteers must be willing to sign informed consent and must be willing to provide samples to be used for research.
Who cannot join
- Pregnant individuals will not be eligible due to potential risks to the fetus associated with radiologic procedures required for biopsy.
- Children will not be eligible because of potential risks from complications due to procedures involved in obtaining the biopsies.
- Normal volunteers with a history of a clotting disorder may not enroll.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Collection of Blood, Fluid, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer or Normal Volunteers
This study will examine blood, bone marrow, tumor and tissue samples from patients with cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer improve initially with chemotherapy, but then have a disease relapse, after which their tumor no longer responds to treatment. Other patients tumors are drug-resistant from the start. The study will look for "resistance factors"-substances in blood and tissues that render tumors resistant to chemotherapy. The findings may provide information needed to develop methods of combating drug resistance.
Patients with cancer who are 18 years or older may be eligible for this study. Participants will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study; additional samples will be obtained periodically during the course of treatment. A small sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor biopsy (removal of a small piece of tumor) for medical reasons or as part of a research treatment protocol. Patients who do not require surgery or biopsy may be asked permission to obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1) withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen; 3) removing a small tumor sample through a needle; or 4) removing the sample with a small incision into or around the tumor. These procedures will be done only if they are of low risk to the patient.
Read the detailed description
Background:
Ongoing research in the Molecular Pharmacology Section, NCI, requires the availability of blood, fluid, bone marrow, tumor, hair follicle and tissue samples from patients with cancer. Resistance is the underlying cause of treatment failure, and may present as acquired or intrinsic drug resistance. Patients with cancer frequently present with chemotherapy-responsive disease, and undergo tumor response, only to eventually experience relapse, at which time the tumor may be refractory to further treatment. This is termed acquired drug resistance; while intrinsic resistance implies a cancer that is refractory from the outset. Diverse mechanisms of drug resistance have been described and are often dependent upon the particular drug under study.
Objectives:
To obtain blood, fluid, hair follicles, bone marrow, tumor and/or normal tissue samples that would allow development of assays for use in subsequent clinical trials.
Eligibility:
Patients with a prior diagnosis of malignancy, with advanced or refractory cancer will be evaluated in the GMB Clinic, NCI.
Participants may be on, or in the process of being evaluated for a research protocol. Participants may receive treatment on the standard care protocol.
Normal volunteers may enroll in the study.
Design:
Acquired samples will be recorded in the computerized data bank currently existing in the Molecular Pharmacology Section. No germline testing will be performed on any of the samples collected. Tests will be pilot studies relating to the Section s work on the biology of drug resistance and cell survival in cancer.
Sample collection for patients with cancer:
- Blood samples, fluid samples, or hair follicle samples may be collected at the initial visit, and at follow up visits.
- Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, or by excisional biopsy, providing the tumor is accessible.
- Bone marrow aspirate, thoracentesis, and paracentesis may be performed.
Normal volunteers may enroll in the study for collection of blood, fluid, and/or hair follicle samples.
Examples of the types of studies to be performed with biopsies will be drug resistance gene expression assays, with the goal of demonstrating the utility of the assay in participant samples.
Evaluation of methods to detect drug resistance proteins and genes will be explored, including Northern blot, immunoblot, polymerase chain reaction assay, and RNA in situ hybridization. With whole blood, we may evaluate the presence of dye transport in an ex vivo assay, for example, using inhibitors of ABCG2. Evidence of drug accumulation or DNA damage may be sought in participant mononuclear cells or in hair follicle samples.
- Conditions
- Renal Cell Carcinoma, Lung Carcinoma, Cervical Carcinoma
- Keywords
- Assays, Resistance, Biopsy Samples, Specimen Acquisition, Cancer Cells, Natural History
- Medical subject headings
- Carcinoma, Renal Cell, Lung Neoplasms, Uterine Cervical 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 | Cancer patients providing tissue for research studies | |
| 2/Normal Volunteers | normal volunteers providing samples for research studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain specimens to develop assays
Obtain sufficient number of samples for a given test.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study start9 Aug 2000
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
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
- NCT00026663
- Sponsor's protocol ID
- 000078
- Other IDs
- 00-C-0078
- Status last verified
- Jun 2024
- First submitted
- 14 Nov 2001
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood, Fluid, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer or Normal Volunteers
- ClinicalTrials.gov ID
- NCT00026663
- Acronym / sponsor ID
- 000078
- Conditions
- Renal Cell Carcinoma, Lung Carcinoma, Cervical Carcinoma
- Keywords
- Assays, Resistance, Biopsy Samples, Specimen Acquisition, Cancer Cells, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Aug 2000 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 15 Nov 2001 (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.
This study will examine blood, bone marrow, tumor and tissue samples from patients with cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer improve initially with chemotherapy, but then have a disease relapse, after which their tumor no longer responds to treatment. Other patients tumors are drug-resistant from the start. The study will look for "resistance factors"-substances in blood and tissues that render tumors resistant to chemotherapy. The findings may provide information needed to develop methods of combating drug resistance.
Patients with cancer who are 18 years or older may be eligible for this study. Participants will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study; additional samples will be obtained periodically during the course of treatment. A small sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor biopsy (removal of a small piece of tumor) for medical reasons or as part of a research treatment protocol. Patients who do not require surgery or biopsy may be asked permission to obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1) withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen; 3) removing a small tumor sample through a needle; or 4) removing the sample with a small incision into or around the tumor. These procedures will be done only if they are of low risk to the patient.
Detailed description
Background:
Ongoing research in the Molecular Pharmacology Section, NCI, requires the availability of blood, fluid, bone marrow, tumor, hair follicle and tissue samples from patients with cancer. Resistance is the underlying cause of treatment failure, and may present as acquired or intrinsic drug resistance. Patients with cancer frequently present with chemotherapy-responsive disease, and undergo tumor response, only to eventually experience relapse, at which time the tumor may be refractory to further treatment. This is termed acquired drug resistance; while intrinsic resistance implies a cancer that is refractory from the outset. Diverse mechanisms of drug resistance have been described and are often dependent upon the particular drug under study.
Objectives:
To obtain blood, fluid, hair follicles, bone marrow, tumor and/or normal tissue samples that would allow development of assays for use in subsequent clinical trials.
Eligibility:
Patients with a prior diagnosis of malignancy, with advanced or refractory cancer will be evaluated in the GMB Clinic, NCI.
Participants may be on, or in the process of being evaluated for a research protocol. Participants may receive treatment on the standard care protocol.
Normal volunteers may enroll in the study.
Design:
Acquired samples will be recorded in the computerized data bank currently existing in the Molecular Pharmacology Section. No germline testing will be performed on any of the samples collected. Tests will be pilot studies relating to the Section s work on the biology of drug resistance and cell survival in cancer.
Sample collection for patients with cancer:
- Blood samples, fluid samples, or hair follicle samples may be collected at the initial visit, and at follow up visits.
- Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, or by excisional biopsy, providing the tumor is accessible.
- Bone marrow aspirate, thoracentesis, and paracentesis may be performed.
Normal volunteers may enroll in the study for collection of blood, fluid, and/or hair follicle samples.
Examples of the types of studies to be performed with biopsies will be drug resistance gene expression assays, with the goal of demonstrating the utility of the assay in participant samples.
Evaluation of methods to detect drug resistance proteins and genes will be explored, including Northern blot, immunoblot, polymerase chain reaction assay, and RNA in situ hybridization. With whole blood, we may evaluate the presence of dye transport in an ex vivo assay, for example, using inhibitors of ABCG2. Evidence of drug accumulation or DNA damage may be sought in participant mononuclear cells or in hair follicle samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Patients with cancer | – | –Cancer patients providing tissue for research studies |
| 2/Normal Volunteers | – | –normal volunteers providing samples for research studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignancy requiring a surgical procedure or biopsy for any medical indication. Healthy volunteers not requiring biopsy for a medical indication.
Key inclusion criteria (7 listed)
Key exclusion criteria (3 listed)
- Pregnant individuals will not be eligible due to potential risks to the fetus associated with radiologic procedures required for biopsy.
- Children will not be eligible because of potential risks from complications due to procedures involved in obtaining the biopsies.
- Normal volunteers with a history of a clotting disorder may not enroll.
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
To obtain specimens to develop assays
Time frame: End of study
Obtain sufficient number of samples for a given test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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. This study is not recruiting at the moment.
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 Renal Cell Carcinoma and Lung Carcinoma, 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 1 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain specimens to develop assays (time frame: End 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 1 Jul 2024.