Clinical Trial: Detection of Peritoneal Micrometastasis in Gastric and Pancreatic Cancer in Peritoneal Wash Samples
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Detection of Peritoneal Micrometastasis in Gastric and Pancreatic Cancer in Peritoneal Wash Samples
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome: The primary objective of this pilot trial is to investigate the ability of quantitative RT-PCR to detect cancer cells in peritoneal washings of patients undergoing laparoscopy for gastric or pancreatic cancer. [ Time Frame: conclusion of study ]
Original Primary Outcome: The primary objective of this pilot trial is to investigate the ability of quantitative RT-PCR to detect cancer cells in peritoneal washings of patients undergoing laparoscopy for gastric or pancreatic cancer. [ Time Frame: March 2008 ]
Current Secondary Outcome: The secondary objective of this pilot study is to estimate the sensitivity, specificity, false positive, and false negative rate of peritoneal cancer cell detection by quantitative RT-PCR. [ Time Frame: conclusion of study ]
Original Secondary Outcome: The secondary objective of this pilot study is to estimate the sensitivity, specificity, false positive, and false negative rate of peritoneal cancer cell detection by quantitative RT-PCR. [ Time Frame: March 2008 ]
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: December 21, 2007
Date Started: March 2006
Date Completion: March 2018
Last Updated: April 3, 2017
Last Verified: April 2017
