Rectal CancerNCT01379612
Ultrasound Elastography in Patients With Rectal Cancer
An observational study of Rectal Cancer, run by Vejle Hospital at 2 sites in Denmark.
Trial summary
The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Ultrasonic Elastography
- How many people
- 31 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2010to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rectal cancer patients planned for preoperative chemoradiation at the Dept. of Oncology, Vejle Hospital, Denmark.
Who may be able to join
- Patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge.
- T3/4 tumor assessed by transrectal ultrasound and MR, and CRMMR < 5 mm.
- Life expectancy of more than 3 months.
- Age ≥18 years.
- Performance status ≤ 2 according to WHO.
- Patient able to observe protocol guidelines.
- Signed informed consent.
Who cannot join
- Previous radiation treatment for the pelvis.
- Known distant metastases.
- Serious disease contraindicating treatment, including cardiovascular disease.
- Other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri.
- Pacemaker
- other disease making the patient unfit for study participation as assessed by investigator
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept. of Oncology, Vejle Hospital
Vejle, 7100
Dept. of Radiology, Vejle Hospital
Vejle, 7100
About this study
Official title: Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation
The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. The objective quantitative elastography findings are compared with the TRG score.
The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.
- Conditions
- Rectal Cancer
- Being tested
- Ultrasonic Elastography
- Keywords
- Ultrasound elastography, Rectal cancer, Preoperative chemoradiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic ElastographyOther
Non-invasive
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer patients in chemoradiation | Not described Receives: Other: Ultrasonic Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor regression grade
Measured: 8 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2012
- Study completionDec 2012
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379612
- Sponsor's protocol ID
- S-20100028
- Status last verified
- Jun 2013
- First submitted
- 8 Jun 2011
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation
- ClinicalTrials.gov ID
- NCT01379612
- Acronym / sponsor ID
- S-20100028
- Conditions
- Rectal Cancer
- Keywords
- Ultrasound elastography, Rectal cancer, Preoperative chemoradiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Jun 2011 (estimated)
- 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.
The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. The objective quantitative elastography findings are compared with the TRG score.
The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer patients in chemoradiation | – | Other: Ultrasonic Elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients planned for preoperative chemoradiation at the Dept. of Oncology, Vejle Hospital, Denmark.
Key inclusion criteria (7 listed)
- Patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge.
- T3/4 tumor assessed by transrectal ultrasound and MR, and CRMMR < 5 mm.
- Life expectancy of more than 3 months.
- Age ≥18 years.
- Performance status ≤ 2 according to WHO.
Key exclusion criteria (6 listed)
- Previous radiation treatment for the pelvis.
- Known distant metastases.
- Serious disease contraindicating treatment, including cardiovascular disease.
- Other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri.
- Pacemaker
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 |
|---|---|---|
| Ultrasonic ElastographyNon-invasive | Other | Rectal cancer patients in chemoradiation |
Primary outcome
Tumor regression grade
Time frame: 8 weeks after operation
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 17 Jun 2013.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Vejle Hospital at 2 sites in Denmark.
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 7 inclusion and 6 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 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Tumor regression grade (time frame: 8 weeks after operation). 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 17 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.