MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients (MMP-7)

May 10, 2017 updated by: Region Skane

Effect of Long and Short Radiotherapy on MMP-7 Levels in Rectal Cancer Treatment

To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

77

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Rectal cancer patients undergoing surgery with or without neoadjuvant radiotherapy

Description

Inclusion Criteria:

Adenocarcinoma of the rectum, ability to understand written and oral information, written consent.

Exclusion Criteria:

Colon cancer, benign tumors, impaired general condition of patient, declining to participate in the study, synchronous colonic tumors, logistical reasons, inability to understand written and/or oral information, previous pelvic irradiation, ongoing immunosuppressive therapy, diabetes with systemic complications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No radiotherapy
Surgery only
25 Gray radiotherapy
Surgery after short term radiotherapy
Radiation: Neoadjuvant radiotherapy
Neoadjuvant radiotherapy prior to rectal cancer surgery
50 Gray radiotherapy
Surgery after long term radiotherapy
Radiation: Neoadjuvant radiotherapy
Neoadjuvant radiotherapy prior to rectal cancer surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Matrilysin levels
Time Frame: 1 - 6 weeks
Inflammatory markers
1 - 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2002

Primary Completion (Actual)

March 16, 2007

Study Completion (Actual)

March 16, 2007

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LU155-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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