NCT02113384

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2012Jan 2028

Study Start

First participant enrolled

September 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

9 years

First QC Date

April 8, 2014

Last Update Submit

July 21, 2021

Conditions

Rectal Cancer

Keywords

Rectal cancerLocally advanced rectal cancerPeritoneal carcinomatosisExfoliated peritoneal cellsPeritoneal lavage

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time from surgery until death from any cause

    5 years

Secondary Outcomes (3)

  • Disease-free survival

    5 years

  • Disease-free survival

    3 years

  • Overall survival

    3 years

Study Arms (1)

Observational study

Patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital.

Other: Observational study.

Interventions

Observational study.OTHER

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.

Also known as: Observational study. Laboratory biomarker analysis.
Observational study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for surgical removal of a primary locally advanced rectal tumor at the Radium Hospital.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Norwegain Radium Hospital

Oslo, Ullern, 0310, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, peritoneal lavage samples, blood specimen.

MeSH Terms

Conditions

Rectal NeoplasmsPeritoneal Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesAbdominal NeoplasmsPeritoneal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Bjørn-Atle Bjørnbeth, MD PhD

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 14, 2014

Study Start

September 1, 2012

Primary Completion

September 1, 2021

Study Completion (Estimated)

January 1, 2028

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

NO(1)