Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 3/30/2019 |
| Start Date: | July 21, 2013 |
| End Date: | June 30, 2024 |
| Contact: | NIH Foregut Team |
| Email: | foregut@mail.nih.gov |
| Phone: | (240) 858-3610 |
Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors
Background:
- Recent advances in cancer research have led to new therapies to treat the disease. It is
important to continue these advances and discover new ones. To do that, researchers need
tissue samples from solid tumors. This study will collect such samples from people already
scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).
Objectives:
- To collect tissue samples for use in studying new ways to treat tumors.
Eligibility:
- Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled
to have surgery or a biopsy at the NIHCC.
Design:
- Before their procedure, participants will have a small blood sample taken.
- Some participants will undergo leukapheresis. In this procedure, blood is removed
through a tube in one arm and circulated through a machine that removes white blood
cells. The blood, minus the white blood cells, is returned through a tube in the other
arm. The procedure takes 3 4 hours.
- For all participants, during the surgery or biopsy, pieces of the tumor and pieces of
normal tissue near it will be removed for this study. The rest of the tumor or
precancerous growth will be sent to a lab for analysis.
- Participants will return to the clinic about 6 weeks after the operation for a routine
checkup. Some may have to return for additional follow-up.
- Recent advances in cancer research have led to new therapies to treat the disease. It is
important to continue these advances and discover new ones. To do that, researchers need
tissue samples from solid tumors. This study will collect such samples from people already
scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).
Objectives:
- To collect tissue samples for use in studying new ways to treat tumors.
Eligibility:
- Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled
to have surgery or a biopsy at the NIHCC.
Design:
- Before their procedure, participants will have a small blood sample taken.
- Some participants will undergo leukapheresis. In this procedure, blood is removed
through a tube in one arm and circulated through a machine that removes white blood
cells. The blood, minus the white blood cells, is returned through a tube in the other
arm. The procedure takes 3 4 hours.
- For all participants, during the surgery or biopsy, pieces of the tumor and pieces of
normal tissue near it will be removed for this study. The rest of the tumor or
precancerous growth will be sent to a lab for analysis.
- Participants will return to the clinic about 6 weeks after the operation for a routine
checkup. Some may have to return for additional follow-up.
BACKGROUND:
- Recent advances and insights into the molecular pathogenesis of cancer have led to the
development of novel molecular and biologic targeted therapies for the treatment of
advanced cancer patients. A critical challenge in extending these studies involves the
identification and validation of new therapeutic targets for future cancer therapies.
- As Surgical Oncologists at the NCI, we have an interest in identifying novel molecular
and biologic targets to facilitate the development of future cancer therapies. In
addition, we have the primary responsibility for providing surgical consultative
services to the NIH. As such, we are uniquely positioned to acquire and perform
important studies on solid tumor tissue to help identify therapeutic targets that may
have significant clinical ramifications.
OBJECTIVES:
- To collect biologic samples from patients undergoing diagnostic, preventative, or
therapeutic interventions for premalignant, primary or metastatic solid tumors for the
purpose of identifying novel molecular and biologic therapeutic targets
ELIGIBILITY:
- Patients greater than or equal to 18 years of age with radiographic evidence or clinical
suspicion of, genetic predisposition for, biochemical evidence of, or
histologically/cytologically proven solid neoplasms who require diagnostic,
preventative, or therapeutic intervention as a part of the diagnosis and /or treatment
and/or follow up for their neoplasm
- Patients without solid tumors in whom a diagnostic, preventative, or therapeutic
intervention is being performed, but for whom surgical quality and safety outcomes data
are generated.
- Patients should have laboratory and physical examination parameters within acceptable
limits by standard of practice guidelines prior to planned intervention
DESIGN:
- A tissue acquisition trial in which tissues will be obtained at the time of intervention
- No investigational therapy will be given.
- It is anticipated that 1000 patients will be enrolled over a period of 10 years
- Recent advances and insights into the molecular pathogenesis of cancer have led to the
development of novel molecular and biologic targeted therapies for the treatment of
advanced cancer patients. A critical challenge in extending these studies involves the
identification and validation of new therapeutic targets for future cancer therapies.
- As Surgical Oncologists at the NCI, we have an interest in identifying novel molecular
and biologic targets to facilitate the development of future cancer therapies. In
addition, we have the primary responsibility for providing surgical consultative
services to the NIH. As such, we are uniquely positioned to acquire and perform
important studies on solid tumor tissue to help identify therapeutic targets that may
have significant clinical ramifications.
OBJECTIVES:
- To collect biologic samples from patients undergoing diagnostic, preventative, or
therapeutic interventions for premalignant, primary or metastatic solid tumors for the
purpose of identifying novel molecular and biologic therapeutic targets
ELIGIBILITY:
- Patients greater than or equal to 18 years of age with radiographic evidence or clinical
suspicion of, genetic predisposition for, biochemical evidence of, or
histologically/cytologically proven solid neoplasms who require diagnostic,
preventative, or therapeutic intervention as a part of the diagnosis and /or treatment
and/or follow up for their neoplasm
- Patients without solid tumors in whom a diagnostic, preventative, or therapeutic
intervention is being performed, but for whom surgical quality and safety outcomes data
are generated.
- Patients should have laboratory and physical examination parameters within acceptable
limits by standard of practice guidelines prior to planned intervention
DESIGN:
- A tissue acquisition trial in which tissues will be obtained at the time of intervention
- No investigational therapy will be given.
- It is anticipated that 1000 patients will be enrolled over a period of 10 years
- INCLUSION CRITERIA
- Patients must be greater than or equal to 18 years of age.
- Patients who have premalignant, primary or metastatic solid tumors based upon either
radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or
histological/cytological analysis that requires surgery or biopsy as part of the
diagnosis, prevention, treatment and/or follow up
- Patients without solid tumors in whom a diagnostic, preventative, or therapeutic
intervention is being performed, but for whom surgical quality and safety outcomes
data are generated.
- Patients should have laboratory and physical examination parameters within acceptable
limits prior to biopsy or surgery.
- Patients must be planning to undergo surgery or biopsy as part of their normal
treatment plan.
- Ability of subject to understand and the willingness to sign a written informed
consent document.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 866-820-4505
Click here to add this to my saved trials
