Overview

This trial is active, not recruiting.

Condition gastric and pancreatic cancer
Treatment washings for experimental marker testing
Sponsor Memorial Sloan Kettering Cancer Center
Start date March 2006
End date March 2016
Trial size 144 participants
Trial identifier NCT00582062, 06-022

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective prospective
Arm
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.
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).
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.
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).

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Men and women 18 years of age and older. - Presentation of gastric or pancreatic cancer based on objective findings on at least one of: CT scan; endoscopy; pathologic examination. - Informed consent, indicating the investigational nature of this study in keeping with the policies of Memorial Sloan-Kettering Cancer Center. - For negative controls, any patient undergoing a laparoscopy for presumed benign disease (e.g., cholecystectomy, hernia repair, BSO) Exclusion Criteria: - Under 18 years of age. - Inability to speak or read English, and an appropriate translator is not identifiable. - Unable or unwilling to give informed consent.

Additional Information

Official title Detection of Peritoneal Micrometastasis in Gastric and Pancreatic Cancer in Peritoneal Wash Samples
Principal investigator Daniel Coit, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.