Protocol Number: 09-C-0079

Title:

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

Number:

09-C-0079

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 (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.

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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