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

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ClinicalTrials.gov Identifier: NCT00923052
Recruitment Status : Terminated
First Posted : June 18, 2009
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


  • 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.


  • 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.


  • 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.


  • 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 or disease
Hepatic Cancer Pancreatic Ductal Cancer Colorectal Cancer Breast Cancer Gastric Cancer

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 190 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Natural History of Solid Organ Cancer Stem Cells (SOCSC)
Study Start Date : February 9, 2009
Estimated Study Completion Date : May 7, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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...

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

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): NCT00923052

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Udo Rudloff, M.D. National Cancer Institute (NCI)

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00923052     History of Changes
Obsolete Identifiers: NCT00892060
Other Study ID Numbers: 090079
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: May 7, 2015

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

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