Studying Stem Cells in Patients With Primary or Metastatic Solid Tumors - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00892060

Purpose

RATIONALE: Studying stem cells in samples of tissue, bone marrow, peritoneal fluid, and blood in the laboratory from patients with solid tumors may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying stem cells in patients with primary or metastatic solid tumors.

Condition	Intervention
Cancer	Genetic: DNA analysis Genetic: DNA methylation analysis Genetic: RNA analysis Genetic: comparative genomic hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: flow cytometry Other: fluorescence activated cell sorting Other: fluorescent antibody technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Condition

Intervention

Cancer

Genetic: DNA analysis
Genetic: DNA methylation analysis
Genetic: RNA analysis
Genetic: comparative genomic hybridization
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymerase chain reaction
Genetic: protein expression analysis
Other: flow cytometry
Other: fluorescence activated cell sorting
Other: fluorescent antibody technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer Soft Tissue Sarcoma Surgery

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Natural History of Solid Organ Cancer Stem Cells (SOCSC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Quantitative and qualitative characterization of solid organ cancer stem cells (SOCSC) from the time of tumor resection to the time of recurrence and/or metastasis using established phenotypic and functional markers of putative cancer stem cells [ Designated as safety issue: No ]

Secondary Outcome Measures:

Presence of SOCSC in blood and/or bone marrow and their quantitative and/or qualitative changes from the time of surgical resection to the time of recurrence and/or metastasis [ Designated as safety issue: No ]
Potential targets in SOCSC that can be used to design novel cancer therapies that specifically target cancer stem cells [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]

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

Detailed Description:

OBJECTIVES:

Primary

To study and characterize, both quantitatively and qualitatively, solid organ cancer stem cells (SOCSC) from the time of tumor resection to the time of recurrence and/or metastasis using established phenotypic and functional markers of putative cancer stem cells from patients with primary or metastatic solid tumors.

Secondary

To determine whether SOCSC are present in the blood and/or bone marrow and study their quantitative and/or qualitative changes from the time of surgical resection to the time of recurrence and/or metastasis.
To analyze SOCSC for potential targets that can be used to design novel cancer therapies that specifically target cancer stem cells.
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.

OUTLINE: Patients undergo tissue (normal and tumor tissue), bone marrow, and/or peritoneal washing sample collection during surgery or biopsy. Patients also undergo blood sample collection prior to surgery or biopsy and then periodically for up to 5 years. Samples are analyzed for gene expression and miRNA expression by microarrays; DNA copy number by array-comparative genomic hybridization; methylation status by methylation arrays; and protein expression. Phenotypic and functional markers of putative cancer stem cells are analyzed by flow cytometry, IHC, immunofluorescence, PCR, MACS and/or FACS, and ELISPOT assay.

After surgery or biopsy, patients are followed periodically for up to 5 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Radiographically, biochemically, and/or histologically/cytologically confirmed solid tumor, including any of the following:
- Hepatobiliary cancer, pancreatic cancer, colorectal cancer, gastric cancer, breast cancer, adrenal cancer, mesothelioma, anal cancer, female reproductive tract cancer (e.g., ovarian, uterine or cervical cancer), melanoma, or sarcoma
- Rare solid tumors*, including, but not limited to, small intestine cancer, vaginal cancer, vulvar cancer, carcinoid, skin cancer, pediatric cancer, Kaposi sarcoma, or cancers of unknown origin NOTE: *Children between the ages of 16 and 18 years with gastrointestinal cancers, melanoma, or sarcoma may participate in this trial as part of the rare cancers group
Patients with premalignant conditions who are scheduled to undergo surgery or biopsy as part of their diagnostic evaluation are eligible
Primary or metastatic disease for which surgery or biopsy are considered acceptable care
- Not planning to undergo surgery or biopsy for the sole purpose of tissue procurement
Able to provide adequate tumor tissue samples
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
ECOG performance status 0-2
Laboratory and physical examination parameters normal (before undergoing biopsy or surgery)

PRIOR CONCURRENT THERAPY:

Concurrent participation in other NIH protocols for treatment of the cancer allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892060

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Itzhak Avital, MD

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000635947, NCI-09-C-0079, NCI-P08488
Study First Received:	May 1, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00892060 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
pancreatic cancer
colon cancer
rectal cancer
gastric cancer
breast cancer
anal cancer
adult soft tissue sarcoma
childhood soft tissue sarcoma
melanoma
skin cancer
cervical cancer
ovarian germ cell tumor
ovarian epithelial cancer

ovarian sarcoma
ovarian stromal cancer
vaginal cancer
vulvar cancer
gastrointestinal carcinoid tumor
small intestine cancer
extrahepatic bile duct cancer
carcinoma of unknown primary
osteosarcoma
chondrosarcoma
childhood rhabdomyosarcoma
malignant mesothelioma
fallopian tube cancer
pulmonary carcinoid tumor
uterine sarcoma

Study placed in the following topic categories:

Fallopian Tube Cancer
Precancerous Conditions
Rectal Neoplasms
Pancreatic Neoplasms
Vulvar Cancer
Vaginal Cancer
Endometrial Cancer
Bile Duct Cancer, Extrahepatic
Anal Cancer
Kaposi Sarcoma
Melanoma
Liver Neoplasms
Soft Tissue Sarcomas
Vulvar Neoplasms
Stomach Neoplasms

Chondrosarcoma
Osteogenic Sarcoma
Immunoglobulins
Rhabdomyosarcoma
Vaginal Neoplasms
Adrenocortical Carcinoma
Sarcoma, Kaposi
Rectal Neoplasm
Breast Neoplasms
Osteosarcoma
Rhabdomyosarcoma, Childhood
Ovarian Epithelial Cancer
Skin Neoplasms
Fallopian Tube Neoplasms
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009