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Trial record 90 of 2838 for:    Pancreatic Cancer

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

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ClinicalTrials.gov Identifier: NCT00582062
Recruitment Status : Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date December 21, 2007
First Posted Date December 28, 2007
Last Update Posted Date April 4, 2019
Actual Study Start Date March 2006
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2008)
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 Measures
 (submitted: December 21, 2007)
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 ]
Change History Complete list of historical versions of study NCT00582062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 10, 2008)
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 Measures
 (submitted: December 21, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection of Peritoneal Micrometastasis in Gastric and Pancreatic Cancer in Peritoneal Wash Samples
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 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.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Gastric and Pancreatic Cancer
Intervention 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).
Study Groups/Cohorts
  • 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.
    Intervention: Other: washings for experimental marker testing
  • 2
    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.
    Intervention: Other: washings for experimental marker testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 6, 2012)
144
Original Estimated Enrollment
 (submitted: December 21, 2007)
130
Estimated Study Completion Date September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00582062
Other Study ID Numbers 06-022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Daniel Coit, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2018