The Natural History of Solid Organ Cancer Stem Cells (SOCSC) - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00923052

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:	Prospective
Official Title:	The Natural History of Solid Organ Cancer Stem Cells (SOCSC)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Liver Cancer Stomach Cancer Surgery

U.S. FDA Resources

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

Estimated Enrollment:	676
Study Start Date:	February 2009
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

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 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.
To collect detailed history, demographic, and treatment data as well as perioperative findings to evaluate potential correlation with the presence or absence of SOCSC.

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).

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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

Contacts

Contact: NCI Referral Office

1-888-NCI-1937

ncicssc@mail.nih.gov

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

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):1065-6. No abstract available.

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

Study ID Numbers:	090079, 09-C-0079
Study First Received:	June 17, 2009
Last Updated:	October 23, 2009
ClinicalTrials.gov Identifier:	NCT00923052 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Cancer Stem Cells
Biomarkers
Surgery
Solid Organ Cancers
Natural History
Cancer

Solid Organ Cancer
Liver Cancer
Colorectal Cancer
Breast Cancer
Gastric Cancer
Pancreatic Ductal Cancer

Additional relevant MeSH terms:

Liver Diseases
Digestive System Neoplasms
Skin Diseases
Gastrointestinal Diseases
Colonic Diseases
Breast Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Liver Neoplasms
Neoplasms
Stomach Diseases
Neoplasms by Site
Digestive System Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Colorectal Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 20, 2009