Protocol Number: 09-C-0079

Title:

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

Number:

09-C-0079

Summary:

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 metastasizing cells are Solid Organ Cancer Stem Cells (SOCSC).

-SOCSC are relatively resistant to current cancer therapies. Thus, effective treatment for metastatic cancers might require the targeting of SOCSC.

-Knowledge on SOCSC is chiefly derived from cell lines. However, data suggest vast differences between cell lines and SOCSC obtained from fresh tumors.

-This protocol is designed to facilitate fresh tissue procurement to study SOCSC.

Primary Objective:

-To study the natural history of SOCSC from various primary and metastatic solid organ cancers using established phenotypic and functional markers from time of tumor resection to time of recurrence and/or metastasis.

Secondary Objectives:

-To analyze SOCSC for potential targets that can be used to design novel cancer therapies that target cancer stem cells.

-To determine whether SOCSC are present in the blood and/or bone marrow, and study their quantitative and/or qualitative changes from time of surgical resection to time of recurrence and/ or metastasis.

-To evaluate the potential of SOCSC and their quantitative and/or qualitative changes over time after surgery, to be used in future studies as biomarkers for the early detection of cancer recurrence and/or metastases.

Eligibility:

-Patients 16 years of age or older with primary or metastatic solid organ cancers requiring resection that is deemed in the best interest of their cancer care.

-Patients with premalignant neoplasms who are scheduled to undergo surgery or biopsy as part of their diagnostic evaluation.

-Patients must have an ECOG performance score of 0-2.

-Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.

Design:

-This is a prospective trial designed to procure SOCSC from various solid organ cancers and follow their natural history from time of surgery (primary or metastatic) to time of recurrence.

-SOCSC will be isolated using phenotypic and functional markers. Investigations will be performed on the following tissues: Blood prior and after surgery, tumor and adjacent normal tissue when available, bone marrow (strictly optional under separate consent), and peritoneal washings when applicable.

-After surgery blood will be drawn at 1 and 3 months and every 3-6 months thereafter during the follow-up period (5 years). Bone marrow may be analyzed every six months during the follow-up period (strictly optional).

-Patients will be followed with standard of care.

-It is anticipated that between 274 and 676 patients will be enrolled over a period of 5 years (2-5 patients per month).

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

-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 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.

-Patients undergoing treatment for their neoplasm under other current NIH protocols may be eligible.

EXCLUSION CRITERIA:

-Patients with solid tumors that surgical resection or biopsy is not part of their acceptable care.

-Patients whose tumors cannot provide enough tissue for these studies.

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

Special Instructions:

Currently Not Provided

Keywords:

Cancer Stem Cells

Biomarkers

Surgery

Solid Organ Cancers

Natural History

Recruitment Keyword(s):

Cancer

Solid Organ Cancer

Liver Cancer

Colorectal Cancer

Breast Cancer

Gastric Cancer

Pancreatic Ductal Cancer

Condition(s):

Hepatic Cancer

Pancreatic Ductal Cancer

Colorectal Cancer

Breast Cancer

Gastric Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Fidler IJ. Critical factors in the biology of human cancer metastasis: twenty-eighth G.H.A. Clowes memorial award lecture. Cancer Res. 1990 Oct 1;50(19):6130-8.

Fidler IJ. Critical factors in the biology of human cancer metastasis. Am Surg. 1995 Dec;61(12):1056-6.

Fidler IJ. Critical determinants of melanoma metastasis. J Investig Dermatol Symp Proc. 1996 Apr;1(2):203-8.

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