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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582062 |
We are undertaking a study of patients with gastric or pancreatic cancer. A common place for cancer to return after surgery for gastric or pancreatic cancer is the inside lining of the abdomen, called "peritoneal metastasis". At the time of surgery, washing the abdomen with a mild salt solution may reveal free cancer cells in the abdomen which could develop into peritoneal metastasis. Recently, surgeons here at Memorial Sloan-Kettering have found that patients who have these cells develop peritoneal metastases and are better treated with chemotherapy rather than surgery. Sometimes, though, these cells might be present but cannot be found by using current techniques. We are trying to figure out a better way to find these free cancer cells. This could improve our treatment of patients with gastric and pancreatic cancer. We need "negative control" population to which we can compare the peritoneal washings of these cancer patients.
Condition | Intervention |
Gastric and Pancreatic Cancer |
Other: washings for experimental marker testing |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
Drug Information available for: | Sodium chloride |
Study Type: | Observational |
Study Design: | Case-Crossover, Prospective |
Official Title: | Detection of Peritoneal Micrometastasis in Gastric and Pancreatic Cancer in Peritoneal Wash Samples |
Estimated Enrollment: | 130 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
1
Positive controls will include patients who have positive cytology or positive biopsy of peritoneal metastases. Cell lines which over-express these tumor markers will also be used as positive controls. Sensitivity will be defined using serial dilutions of several established gastric and pancreatic tumor cell lines. The mRNA of the tumor markers will be normalized to glyceraldehyde-3-phosphate dehydrogenase mRNA expression.
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Other: washings for experimental marker testing
During the laparoscopy, a small amount of a mild salt solution will be introduced to gently wash the inside of the abdomen. The fluid will be removed and sent to the laboratory for two analyses: 1) washings for cytology (routine), and 2) washings for experimental marker testing (experimental).
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Patients who are scheduled to undergo laparoscopy for benign disease (e.g., laparoscopic cholecystectomy, hernia repair, or prophylactic BSO) will be recruited as negative controls. A leukemia cell line which does not express epithelial cell markers will also be used as a negative control for the RT-PCR reactions.
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Other: washings for experimental marker testing
During the laparoscopy, a small amount of a mild salt solution will be introduced to gently wash the inside of the abdomen. The fluid will be removed and sent to the laboratory for two analyses: 1) washings for cytology (routine), and 2) washings for experimental marker testing (experimental).
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Positive peritoneal cytology is a predictor of poor outcome in gastric cancer. These patients generally have a prognosis similar to patients who are clinically or radiologically classified as having Stage IV disease. Similar, although fewer, observations have been made in patients with pancreatic cancer. If identified prior to scheduled resection, an extensive operation may not be required. The purpose of this pilot trial is to investigate the ability of a quantitative RT-PCR assay to detect cancer cells in peritoneal washings of patients undergoing laparoscopy for gastric or pancreatic cancer. This assay may detect mRNA overly expressed in gastric or pancreatic cancer patients with malignant cells in the peritoneum which cannot be detected by less sensitive means. Results of this assay will be compared to cytology results, as detected by standard Papanicolaou staining, during routine laparoscopic peritoneal washings in the absence of visible M1 disease. We anticipate enrolling 50 gastric cancer patients and 50 pancreatic cancer patients who will be undergoing laparoscopy as part of their initial management. We plan to enroll 30 patients undergoing laparoscopy for a presumed benign condition (e.g., gallstones, prophylactic bilateral salpingo-oophorectomy [BSO]) as negative controls. We estimate accrual will take approximately 12 months. Once this assay is established with this pilot study, we plan to evaluate prospectively the incidence, predictors, and clinical significance of positive cytology, as detected by standard Papanicolaou stainingand RT-PCR of tumor markers. This study does not conflict with any existing protocol at Memorial Hospital.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Eligible patients will be those with a diagnosis of gastric or pancreatic cancer who present to the Surgical Services at Memorial Sloan-Kettering Cancer Center, who are candidates for surgical treatment, and are scheduled for laparoscopy.
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel Coit, MD | coitd@mskcc.org |
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10065 | |||||
Contact: Daniel Coit, MD coitd@mskcc.org |
Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Daniel Coit, MD | Memorial Sloan-Kettering Cancer Center |
Memorial Sloan-Kettering Cancer Center website 
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Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Daniel Coit, MD ) |
Study ID Numbers: | 06-022 |
First Received: | December 21, 2007 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00582062 |
Health Authority: | United States: Food and Drug Administration |
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