Rectal CancerRECTOMICSNCT04920435
Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Medical Imaging
An observational study of Rectal Cancer, run by University Hospital, Brest at 3 sites in France.
Trial summary
In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population. Radiomics features provide complementary information about tumor heterogenity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 124 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Jan 2019to 31 Dec 2019
- 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: Patient with locally advanced rectal cancer
Who may be able to join
- locally advanced rectal cancer
- patients who received concomitant radio-chemotherapy followed by surgery
- pre-therapeutic MRI and CT-scan dicom available
Who cannot join
- age under 18 yo
- lack of MRI or CT-scan
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Brest (Morvan)
Brest
ICO
Nantes, Saint Herblain, 44800
Centre Hospitalier de Cornouaille
Quimper, Brittany Region, 29000
About this study
Official title: Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Magnetic Resonance Imaging, Contrast Injection Computed Tomography and Positron Emission Tomography at 18-FDG in Locally Advanced Rectal Cancer
In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population.
Radiomics features provide complementary information about tumor heterogenity.
The aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.
- Conditions
- Rectal Cancer
- Keywords
- locally advanced rectal cancer, radiomic
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| training population | patients from which we will develop the prediction model | |
| testing population | patients on whom we will test the prediction model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of the complete response (pCR) to neoadjuvant chemoradiotherapy
defined as the absence of tumor residue on the surgical specimen, ypT0N0
Measured: TO = Immediately after biopsy and extension evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start2 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920435
- Sponsor's protocol ID
- RECTOMICS (29BRC20.0027)
- Acronym
- RECTOMICS
- Status last verified
- Nov 2021
- First submitted
- 3 Jun 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Magnetic Resonance Imaging, Contrast Injection Computed Tomography and Positron Emission Tomography at 18-FDG in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04920435
- Acronym / sponsor ID
- RECTOMICS / RECTOMICS (29BRC20.0027)
- Conditions
- Rectal Cancer
- Keywords
- locally advanced rectal cancer, radiomic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 9 Jun 2021 (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.
In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population.
Radiomics features provide complementary information about tumor heterogenity.
The aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training population | – | –patients from which we will develop the prediction model |
| testing population | – | –patients on whom we will test the prediction model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with locally advanced rectal cancer
Key inclusion criteria (3 listed)
- locally advanced rectal cancer
- patients who received concomitant radio-chemotherapy followed by surgery
- pre-therapeutic MRI and CT-scan dicom available
Key exclusion criteria (2 listed)
- age under 18 yo
- lack of MRI or CT-scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of the complete response (pCR) to neoadjuvant chemoradiotherapy
Time frame: TO = Immediately after biopsy and extension evaluation.
defined as the absence of tumor residue on the surgical specimen, ypT0N0
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 7 Dec 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
3 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 University Hospital, Brest at 3 sites in France.
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 3 inclusion and 2 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 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Prediction of the complete response (pCR) to neoadjuvant chemoradiotherapy (time frame: TO = Immediately after biopsy and extension evaluation.). 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 7 Dec 2021.