Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026663
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2001-11-14
Brief Title:
Collection of Blood Bone Marrow Tumor or Tissue Samples From Patients With Cancer to Study Drug Resistance
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Blood Fluid Bone Marrow Tumor or Tissue Samples From Patients With Cancer or Normal Volunteers
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 andor 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 andor 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
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 andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-0078 | None | None | None |