Status:

TERMINATED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Hepatic Cancer

Pancreatic Ductal Cancer

Eligibility:

All Genders

16-100 years

Brief Summary

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 (...

Detailed Description

Background: * Traditional models of cancer metastasis posit that cancer metastases might originate stochastically in any cancer cell while, the Cancer-Stem-Cell hypothesis suggests that the metastasi...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    February 9 2009

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    May 7 2015

    Estimated Enrollment :

    190 Patients enrolled

    Trial Details

    Trial ID

    NCT00923052

    Start Date

    February 9 2009

    End Date

    May 7 2015

    Last Update

    December 16 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892