The Natural History of Solid Organ Cancer Stem Cells (SOCSC)
This study is currently recruiting participants.
Verified July 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923052
First received: June 17, 2009
Last updated: December 19, 2012
Last verified: July 2012
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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: | Time Perspective: Prospective |
| Official Title: | The Natural History of Solid Organ Cancer Stem Cells (SOCSC) |
Resource links provided by NLM:
Further study details as provided by National Institutes of Health Clinical Center (CC):
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923052
Contacts
| Contact: Melissa A Walker, R.N. | (301) 402-9537 | walkerme@mail.nih.gov |
| Contact: Steven A Rosenberg, M.D. | (301) 496-4164 | sar@mail.nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Steven A Rosenberg, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00923052 History of Changes |
| Obsolete Identifiers: | NCT00892060 |
| Other Study ID Numbers: | 090079, 09-C-0079 |
| Study First Received: | June 17, 2009 |
| Last Updated: | December 19, 2012 |
| 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:
|
Breast Neoplasms Colorectal Neoplasms Liver Neoplasms Stomach Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Liver Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on May 21, 2013