Low Anterior Resection SyndromePORTLARSNCT05129215
Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
An observational study of Low Anterior Resection Syndrome and Radiotherapy, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Anterior Resection Syndrome, Radiotherapy, Rectal Cancer
- What is being tested?
- Questionnaire
- How many people
- 901 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2020to 31 Oct 2022
- 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: Patients who underwent preoperative radiotherapy and curative low anterior resection for nonmetastatic rectal cancer.
Who may be able to join
- Curative low anterior resection for nonmetastatic rectal cancer
- Preoperative radiotherapy
Who cannot join
- Death
- Metastasis or recurrence
- Postoperative radiotherapy
- Cognitive disorder
- Intestinal stoma
- Rectal cancer resection for <12 months
- Stoma reversal for <6 months
Trial locations and contacts
1 site in 1 country.
China1 site
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Development and Validation of a Nomogram to Predict Severe Bowel Dysfunction After Rectal Cancer Resection and Neoadjuvant Radiotherapy: A Multicenter, Observational Clinical Study
Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. This multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the LARS score, and to build a model that predicts long-term major LARS in the early stage of follow-up. Development and validation cohorts are enrolled from tertiary hospitals in China.
- Conditions
- Low Anterior Resection Syndrome, Radiotherapy, Rectal Cancer
- Being tested
- Questionnaire
- Keywords
- Bowel Dysfunction, Low Anterior Resection Syndrome, Radiotherapy, Rectal Cancer
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The LARS score is used for assessment of bowel dysfunction after rectal cancer resection.
| Study group | Role | What they receive |
|---|---|---|
| Development | A primary cohort of eligible patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model derivation. Receives: Other: Questionnaire | |
| Internal cross-validation | A cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for internal cross-validation. Receives: Other: Questionnaire | |
| External validation | An independent cohort of eligible patients from other hospitals is used for external validation. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
The AUC of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.
The AUC is evaluated by calculating the area under curve of receiver operating characteristics which plots the proportion of true positive cases (sensitivity) against the proportion of false positive cases (1-specificity) based on various predictive probability threshold.
Measured: Over one year after restorative rectal cancer resection
Secondary outcomes (4)
Sensitivity
The sensitivity of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.
Model sensitivity is evaluated by calculating the proportion of the 'predicted major LARS' subjects among the total 'actual major LARS' subjects.
Measured: Over one year after restorative rectal cancer resection
Specificity
The specificity of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.
Model specificity is evaluated by calculating the proportion of the 'predicted no/minor LARS' subjects among the total 'actual no/minor LARS' subjects.
Measured: Over one year after restorative rectal cancer resection
Positive prediction value (PPV)
The PPV of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.
Model PPV is evaluated by calculating the proportion of the 'actual major LARS' subjects among the total 'predicted major LARS' subjects.
Measured: Over one year after restorative rectal cancer resection
Negative prediction value (NPV)
The NPV of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy.
Model NPV is evaluated by calculating the proportion of the 'actual no/minor LARS' subjects among the total 'predicted no/minor LARS' subjects.
Measured: Over one year after restorative rectal cancer resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start6 Mar 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Anterior Resection SyndromeStudies 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
- Cross-sectional
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Beijing Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Qiyuan Qin, M.D., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129215
- Sponsor's protocol ID
- E2020016
- Acronym
- PORTLARS
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qin Q, Huang B, Wu A, Gao J, Liu X, Cao W, Ma T, Kuang Y, Guo J, Wu Q, Shao B, Guan Q, Yao H, Zhang X, Wang H; Chinese Radiation Intestinal Injury Research Group. Development and Validation of a Post-Radiotherapy Prediction Model for Bowel Dysfunction After Rectal Cancer Resection. Gastroenterology. 2023 Dec;165(6):1430-1442.e14. doi: 10.1053/j.gastro.2023.08.022. Epub 2023 Aug 23.
PubMed 37625498
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Nomogram to Predict Severe Bowel Dysfunction After Rectal Cancer Resection and Neoadjuvant Radiotherapy: A Multicenter, Observational Clinical Study
- ClinicalTrials.gov ID
- NCT05129215
- Acronym / sponsor ID
- PORTLARS / E2020016
- Conditions
- Low Anterior Resection Syndrome, Radiotherapy, Rectal Cancer
- Keywords
- Bowel Dysfunction, Low Anterior Resection Syndrome, Radiotherapy, Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Beijing Friendship Hospital
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 22 Nov 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.
Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. This multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the LARS score, and to build a model that predicts long-term major LARS in the early stage of follow-up. Development and validation cohorts are enrolled from tertiary hospitals in China.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Development | – | Other: QuestionnaireA primary cohort of eligible patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for model derivation. |
| Internal cross-validation | – | Other: QuestionnaireA cohort of consecutive patients from the Sixth Affiliated Hospital of Sun Yat-sen University is used for internal cross-validation. |
| External validation | – | Other: QuestionnaireAn independent cohort of eligible patients from other hospitals is used for external validation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent preoperative radiotherapy and curative low anterior resection for nonmetastatic rectal cancer.
Key inclusion criteria (2 listed)
- Curative low anterior resection for nonmetastatic rectal cancer
- Preoperative radiotherapy
Key exclusion criteria (7 listed)
- Death
- Metastasis or recurrence
- Postoperative radiotherapy
- Cognitive disorder
- Intestinal stoma
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 |
|---|---|---|
| QuestionnaireThe LARS score is used for assessment of bowel dysfunction after rectal cancer resection. | Other | Development, External validation, Internal cross-validation |
Primary outcome
Area under the curve (AUC)
Time frame: Over one year after restorative rectal cancer resection
The AUC of PORTLARS in predicting major bowel dysfunction after restorative rectal cancer resection with neoadjuvant radiotherapy. The AUC is evaluated by calculating the area under curve of receiver operating characteristics which plots the proportion of true positive cases (sensitivity) against the proportion of false positive cases (1-specificity) based on various predictive probability threshold.
4 secondary outcomes
Sensitivity
Time frame: Over one year after restorative rectal cancer resection
Specificity
Time frame: Over one year after restorative rectal cancer resection
Positive prediction value (PPV)
Time frame: Over one year after restorative rectal cancer resection
Negative prediction value (NPV)
Time frame: Over one year after restorative rectal cancer resection
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 30 Nov 2022.
- Derived from this study: PubMed 37625498Qin Q, Huang B, Wu A, Gao J, Liu X, Cao W, Ma T, Kuang Y, Guo J, Wu Q, Shao B, Guan Q, Yao H, Zhang X, Wang H; Chinese Radiation Intestinal Injury Research Group. Development and Validation of a Post-Radiotherapy Prediction Model for Bowel Dysfunction After Rectal Cancer Resection. Gastroenterology. 2023 Dec;165(6):1430-1442.e14. doi: 10.1053/j.gastro.2023.08.022. Epub 2023 Aug 23.
- Individual participant dataSharing planned: Undecided
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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.
Qiyuan Qin, M.D. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Anterior Resection Syndrome and Radiotherapy, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 2 inclusion and 7 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Area under the curve (AUC) (time frame: Over one year after restorative rectal cancer resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129215, which also lists 1 linked publication.
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 30 Nov 2022.