The Natural History of Solid Organ Cancer Stem Cells (SOCSC)
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|ClinicalTrials.gov Identifier: NCT00923052|
Recruitment Status : Terminated
First Posted : June 18, 2009
Last Update Posted : February 15, 2018
- 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.
- 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.
- 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.
- 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 or disease|
|Hepatic Cancer Pancreatic Ductal Cancer Colorectal Cancer Breast Cancer Gastric Cancer|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||190 participants|
|Official Title:||The Natural History of Solid Organ Cancer Stem Cells (SOCSC)|
|Study Start Date :||February 9, 2009|
|Estimated Study Completion Date :||May 7, 2015|
- To study and characterize both quantitatively and qualitatively SOCSC from various primary and metastatic solid organ cancers from time of surgery or other cancer directed therapy to time of recurrence or progression using an exhaustive list of ...
- To determine whether SOCSC are present in the blood and/or bone marrow, and study their quantitative and/or qualitative changes over the course of the disease, from time of initial presentation to time of recurrence and/or metastasis.To sp...
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923052
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Udo Rudloff, M.D.||National Cancer Institute (NCI)|