The Natural History of Solid Organ Cancer Stem Cells (SOCSC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923052
First received: June 17, 2009
Last updated: July 1, 2014
Last verified: June 2014
  Purpose

Background:

  • Researchers are trying to learn what causes certain types of cancer to spread to other organs in the body (metastasis). Cancer tumors may produce a very small number of specific cells (cancer stem cells) that cause the tumors to grow in other organs throughout the body.
  • By examining cancer tumor tissue, normal tissue, blood, bone marrow, and other body fluids, researchers may determine whether these samples contain cancer stem cells. Cancer stem cells may provide information on whether the cancer will come back or spread before other routine x-ray studies or lab tests indicate its presence.

Objectives:

  • To acquire a collection of solid organ cancer stem cells for future study.
  • To analyze solid organ cancer stem cells from various types of cancer on a genetic level.
  • To determine if solid organ cancer stem cells are present in the blood or bone marrow.

Eligibility:

  • Patients 16 years of age and older who have solid organ cancer (cancer in the liver, colon, rectum, anus, pancreas, stomach, breast, skin, muscles, fat, connective tissue, uterus, ovary, cervix, vagina, vulva, or inner lining of the abdomen) or a precancerous growth, and who are scheduled to have a biopsy or surgery to remove the cancer as part of their treatment.

Design:

  • This is a prospective trial designed to procure solid organ cancer stem cells before either surgery or biopsy.
  • All patients registered to this trial will undergo surgery to extirpate their cancer in the NCI
  • Prior to surgery or biopsy, 8 tablespoons of blood will be drawn.
  • During the surgery or biopsy, a sample of normal tissue will be removed along with the cancerous or precancerous tissue. If separate consent is given, samples of bone marrow will also be taken.
  • After discharge, patients will return to the clinic for routine visits every month for the first 3 months following surgery, and then about every 3 months for 2 years, and then every 6 months for 3 years. During the visits, patients will have routine blood and imaging studies done, and researchers will take additional blood samples (about 8 tablespoons at each visit) and optional bone marrow samples (4 teaspoons every 6 months) to be used for research.

Condition
Hepatic Cancer
Pancreatic Ductal Cancer
Colorectal Cancer
Breast Cancer
Gastric Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Natural History of Solid Organ Cancer Stem Cells (SOCSC)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To study and characterize both quantitatively and qualitatively SOCSC from various primary and metastatic solid organ cancers from time of surgery or other cancer directed therapy to time of recurrence or progression using an exhaustive list of ...

Secondary Outcome Measures:
  • To determine whether SOCSC are present in the blood and/or bone marrow, and study their quantitative and/or qualitative changes over the course of the disease, from time of initial presentation to time of recurrence and/or metastasis.To sp...

Estimated Enrollment: 676
Study Start Date: February 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA: (Beginning with amendment J, all patients must meet the first eligibility criteria a. Patients scheduled to underg

surgery must meet criteria b-e.)

  • Patients with radiographic evidence of, biochemical evidence of, and/or histologically/cytologically proven solid organ cancer, including hepatobiliary cancer, pancreatic cancer, colorectal cancer, gastric cancer, breast cancer, adrenal cancer, mesothelioma, anal cancer, female reproductive tract cancer (ovarian, uterine and cervical), melanoma, and sarcoma.
  • Patients with rare solid organ cancers including but not limited to small intestine, vagina, vulva, carcinoid, skin, pediatric cancers, Kaposi s sarcoma, and cancers of unknown origin.
  • Patients with premalignant neoplasms who are scheduled to undergo surgery or biopsy as part of their diagnostic evaluation.
  • Patients with a family history of familial or hereditary solid organ cancers or a clinical suspicion for a familial cancer (these patients may show no evidence of disease at the time of enrollment).
  • Patients must have an ECOG performance score of 0-2.
  • Patients must be 16 years of age or older.
  • Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery. Note: Not applicable for healthy relatives having blood analyzed for DNA only.
  • Patients must be seronegative for HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody, with the exception of patients with hepatocellular cancers, who must be seronegative for HIV antibody only. Note: Not applicable for healthy relatives having blood analyzed for DNA only.
  • Patients undergoing treatment for their neoplasm under other current NIH protocols may be eligible.

Note: Patients will not undergo surgery or biopsy for the sole purpose of tissue procurement.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923052

Contacts
Contact: Udo Rudloff, M.D. (301) 496-3098 rudloffu@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 National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Udo Rudloff, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00923052     History of Changes
Obsolete Identifiers: NCT00892060
Other Study ID Numbers: 090079, 09-C-0079
Study First Received: June 17, 2009
Last Updated: July 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cancer Stem Cells
Solid Organ Cancers
Cancer
Solid Organ Cancer
Liver Cancer
Colorectal Cancer
Breast Cancer
Gastric Cancer
Pancreatic Ductal Cancer
Biomarkers
Surgery
Natural History

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Stomach Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Breast Diseases
Skin Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 24, 2014