Rectal CancerMMP-7NCT03151759
MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients
An observational study of Rectal Cancer, run by Region Skane.
Trial summary
To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Neoadjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2002to 16 Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Rectal cancer patients undergoing surgery with or without neoadjuvant radiotherapy
Who may be able to join
- Adenocarcinoma of the rectum, ability to understand written and oral information, written consent.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Rectal Cancer
- Being tested
- Neoadjuvant radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant radiotherapyRadiation
Neoadjuvant radiotherapy prior to rectal cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| No radiotherapy | Surgery only | |
| 25 Gray radiotherapy | Surgery after short term radiotherapy Receives: Radiation: Neoadjuvant radiotherapy | |
| 50 Gray radiotherapy | Surgery after long term radiotherapy Receives: Radiation: Neoadjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matrilysin levels
Inflammatory markers
Measured: 1 - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start6 Nov 2002
- Primary completion16 Mar 2007
- Study completion16 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151759
- Sponsor's protocol ID
- LU155-01
- Acronym
- MMP-7
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long and Short Radiotherapy on MMP-7 Levels in Rectal Cancer Treatment
- ClinicalTrials.gov ID
- NCT03151759
- Acronym / sponsor ID
- MMP-7 / LU155-01
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 6 Nov 2002 (actual)
- Primary completion
- 16 Mar 2007 (actual)
- Study completion
- 16 Mar 2007 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No radiotherapy | – | –Surgery only |
| 25 Gray radiotherapy | – | Radiation: Neoadjuvant radiotherapySurgery after short term radiotherapy |
| 50 Gray radiotherapy | – | Radiation: Neoadjuvant radiotherapySurgery after long term radiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Rectal cancer patients undergoing surgery with or without neoadjuvant radiotherapy
Key inclusion criteria (1 listed)
- Adenocarcinoma of the rectum, ability to understand written and oral information, written consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant radiotherapyNeoadjuvant radiotherapy prior to rectal cancer surgery | Radiation | 25 Gray radiotherapy, 50 Gray radiotherapy |
Primary outcome
Matrilysin levels
Time frame: 1 - 6 weeks
Inflammatory markers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matrilysin levels (time frame: 1 - 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.