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Collecting Solid Tumor Tissue to Identify New Treatments

This study is currently recruiting participants.
Verified October 3, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01658917
First Posted: August 7, 2012
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

Background:

The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.

Objective:

This study will allow tissue samples obtained during the protocol screening process to be used for future and ongoing research in the NCI Surgery Branch

Eligibility:

Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment Protocol

Design

Patients will undergo testing and evaluations as required by the appropriate NCI Surgery Branch Treatment protocol


Condition
Gastrointestinal Cancer Liver Cancer Pancreatic Cancer Melanoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets [ Time Frame: at time of surgery or biospy ]

Secondary Outcome Measures:
  • To collect detailed history, demographic, treatment data, and perioperative findings in order to categorize and track the specific procedures and outcomes. [ Time Frame: at time of consent ]

Estimated Enrollment: 1000
Study Start Date: July 19, 2012
Detailed Description:

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.
  • The Surgery Branch, NCI has 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:

- Primary Objective: To collect biologic samples from patients undergoing diagnostic 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 of, biochemical evidence of, or histologically/cytologically proven solid neoplasms who require diagnostic or therapeutic intervention as a part of the diagnosis and /or standard of care treatment and/or follow up for their neoplasm
  • Patients must 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
  • Tissue and blood will be processed at the time of collection, stored and then transferred to Dr. Kammula s laboratory for further processing.
  • No investigational therapy will be given.
  • It is anticipated that 1000 patients will be enrolled over a period of 10 years
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Patients must be greater than or equal to 18 years of age.
  • Patients who have a premalignant, primary or metastatic solid tumors based upon either radiographic or biochemical testing, or histological/cytological analysis that requires surgery or biopsy as a part of the standard of care diagnosis, treatment and/or follow up
  • Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.
  • Patients must be planning to undergo surgery or biopsy as part of their treatment plan. Note: Patients will not be enrolled exclusively for the procurement of tissue samples.
  • Patients who agree to undergo leukapheresis must meet the following criteria:
  • Seronegative for HIV
  • Seronegative for hepatitis B surface antigen and seronegative for

antibody to hepatitis C.

- CBC within normal limits

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658917


Contacts
Contact: Steven A Rosenberg, M.D. (866) 820-4505 ncisbirc@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center    866-820-4505    ncisbirc@mail.nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01658917     History of Changes
Other Study ID Numbers: 120175
12-C-0175
First Submitted: August 3, 2012
First Posted: August 7, 2012
Last Update Posted: October 19, 2017
Last Verified: October 3, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Tissue Acquisition

Additional relevant MeSH terms:
Pancreatic Neoplasms
Liver Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Gastrointestinal Diseases