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Trial record 3 of 989 for:    scale | Norway

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

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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

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.

Condition or disease Intervention/treatment
Rectal Cancer Other: Observational study.

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Observational Study of Exfoliated Peritoneal Tumor Cells in Locally Advanced Rectal Cancer
Study Start Date : September 2012
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2028

Group/Cohort Intervention/treatment
Observational study
Patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital.
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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
  2. Disease-free survival [ Time Frame: 3 years ]
  3. Overall survival [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Tumor tissue, peritoneal lavage samples, blood specimen.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Radium Hospital.
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113384


Contacts
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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

Locations
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Norway
The Norwegain Radium Hospital Recruiting
Oslo, Ullern, Norway, 0310
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   
Principal Investigator: Kjersti Flatmark, MD PhD         
Principal Investigator: Stein G Larsen, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Investigators
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Study Chair: Bjørn-Atle Bjørnbeth, MD PhD Oslo University Hospital

Additional Information:

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Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02113384     History of Changes
Other Study ID Numbers: Larc-Ex_09/2012
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Oslo University Hospital:
Rectal cancer
Locally advanced rectal cancer
Peritoneal carcinomatosis
Exfoliated peritoneal cells
Peritoneal lavage

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases