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Detection of Peritoneal Micrometastasis in Gastric and Pancreatic Cancer in Peritoneal Wash Samples


N/A
18 Years
N/A
Open (Enrolling)
Both
Gastric and Pancreatic Cancer

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Trial Information

Detection of Peritoneal Micrometastasis in Gastric and Pancreatic Cancer in Peritoneal Wash Samples


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Crossover, Time Perspective: Prospective

Outcome 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.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Daniel Coit, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

06-022

NCT ID:

NCT00582062

Start Date:

March 2006

Completion Date:

March 2013

Related Keywords:

  • Gastric and Pancreatic Cancer
  • Gastric Cancer
  • Pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021