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Trial record 3 of 1079 for:    scale | Norway

Locally Advanced Rectal Cancer - Exfoliated Peritoneal Tumor Cells (LARC-EX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02113384
Recruitment Status : Recruiting
First Posted : April 14, 2014
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Oslo University Hospital

Tracking Information
First Submitted Date April 8, 2014
First Posted Date April 14, 2014
Last Update Posted Date October 16, 2015
Study Start Date September 2012
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 14, 2015)
Overall survival [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: April 10, 2014)
  • Overall survival [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT02113384 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 14, 2015)
  • Disease-free survival [ Time Frame: 5 years ]
  • Disease-free survival [ Time Frame: 3 years ]
  • Overall survival [ Time Frame: 3 years ]
Original Secondary Outcome Measures
 (submitted: April 10, 2014)
  • Disease-free survival [ Time Frame: 5 years ]
  • Disease-free survival [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Locally Advanced Rectal Cancer - Exfoliated Peritoneal Tumor Cells
Official Title Prospective Observational Study of Exfoliated Peritoneal Tumor Cells in Locally Advanced Rectal Cancer
Brief Summary During the course of tumor growth and possibly by manipulation during the surgical procedure, cells from rectal tumors may be shed into the peritoneal cavity. Such cells may give rise to local recurrence or contribute to the formation of metastatic disease, specifically in the form of peritoneal carcinomatosis. Detection of cancer cells in the peritoneal cavity at the time of surgery might therefore be of value for prediction of disease recurrence with subsequent prognostic implications for these patients. In this study the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC.
Detailed Description The investigators recently published a study investigating the incidence of exfoliated cancer cells in peritoneal lavage fluid after resection of locally advanced rectal cancer (LARC). DNA isolated from cells obtained by peritoneal lavage was analyzed by denaturing capillary electrophoresis with respect to mutations in hotspots of the K-RAS gene. This gene is mutated in 30% of rectal tumors. Exfoliated tumor cells (as assessed by the presence of mutated DNA) were found in lavage fluid from 19/237 of the patients, and the presence of tumor cells was associated with poor overall survival. Based on these encouraging results the investigators have designed a more comprehensive prospective study, using a novel, validated set of cancer specific DNA methylation - based biomarkers present in the vast majority of all colorectal tumors (sensitivity 94%, specificity 98%).Using these tumor cell associated biomarkers, the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC. Lavage will be performed prior to and after manipulation of the tumor to provide data regarding both spontaneous and iatrogenic tumor cell exfoliation and their respective contribution to patient outcome. If detection of exfoliated tumor cells is predictive of tumor recurrence, this would support an active approach to postoperative chemotherapy, possibly in the form of intraperitoneal chemotherapy.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Tumor tissue, peritoneal lavage samples, blood specimen.
Sampling Method Non-Probability Sample
Study Population Patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Radium Hospital.
Condition Rectal Cancer
Intervention Other: Observational study.
Biobanking of tissue (tumor biopsy, peritoneal lavage, blood specimen) from patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital.
Other Name: Observational study. Laboratory biomarker analysis.
Study Groups/Cohorts Observational study
Patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital.
Intervention: Other: Observational study.
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 Recruiting
Estimated Enrollment
 (submitted: April 10, 2014)
160
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2028
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Norwegian Radium Hospital.
  • age > 18 years
  • written informed consent

Exclusion criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kjersti Flatmark, MD PhD + 47 22 78 18 63 Kjersti.Flatmark@rr-research.no
Contact: Annette T Kristensen, PhD + 47 22 78 23 12 atj@ous-hf.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT02113384
Other Study ID Numbers Larc-Ex_09/2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators The Research Council of Norway
Investigators
Study Chair: Bjørn-Atle Bjørnbeth, MD PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date October 2015