Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00582062 |
| Other study ID # |
06-022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2006 |
| Est. completion date |
May 2, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Memorial Sloan Kettering Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
