Rectal NeoplasmsCOMRECNCT05871762
Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer
An observational study of Rectal Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Registry study, no specific intervention
- How many people
- 3,705 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2023to 17 May 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: mid-low rectal cancer patients
Who may be able to join
- pathologically confirmed rectal adenocarcinoma
- located within 12cm below the anal verge
Who cannot join
- diagnosed with distant metastasis
- multiple primary colorectal cancers
- history of previous malignant tumors
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiao Yi, +86 13366036387, xiaoy@pumch.cn
About this study
Official title: Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer-a National Multi-center, Prospective, Real World Study
The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.
- Conditions
- Rectal Neoplasms
- Being tested
- Registry study, no specific intervention
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registry study, no specific interventionOther
Registry study, no specific intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year OS
3-year overall survival
Measured: 3 years
Secondary outcomes (10)
3-year DFS
3-year disease-free survival
Measured: 3 years
3-year LR
3-year local recurrence rate
Measured: 3 years
3-year distant metastasis rate
3-year distant metastasis rate
Measured: 3 years
neoadjuvant therapy rate
the percentage of patients who underwent standard neoadjuvant therapy
Measured: at the time point of surgery of the primary lesion
adjuvant therapy rate
the percentage of patients who underwent standard adjuvant therapy
Measured: at the time point of 3-year follow up
EUS/MRI assessment rate
the percentage of patients who underwent standard rectal EUS/MRI assessment
Measured: at the time point of surgery of the primary lesion
R0 resection rate
the percentage of patients who underwent R0 resection
Measured: at the time point of surgery of the primary lesion
CCR
Clinical Complete Response
Measured: immediately after the completion of neoadjuvant therapy assessment
pCR
Pathologic Complete Response
Measured: immediately after the completion of surgery
30-day mortality
death occurring within 30 days of the surgery
Measured: 30 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start4 Jun 2023
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Prospective
- Enrolment
- 3,705 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871762
- Sponsor's protocol ID
- 2022-PUMCH-C-027
- Acronym
- COMREC
- Status last verified
- Aug 2023
- First submitted
- 10 May 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of the Optimal Treatment Strategies for Mid-low REctal Cancer-a National Multi-center, Prospective, Real World Study
- ClinicalTrials.gov ID
- NCT05871762
- Acronym / sponsor ID
- COMREC / 2022-PUMCH-C-027
- Conditions
- Rectal Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,705 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 4 Jun 2023 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 23 May 2023 (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.
The purpose of this study is to compare the efficacy, prognosis, health economics of different treatment modalities of mid-low rectal cancer in different centers in China, and to conduct cost utility analysis (CUA) on the treatment process of rectal cancer to explore the best treatment modality that meets the actual need of medical units in each region and at each level. The investigators hope to provide evidence-based medical suggestions for medical quality control of rectal cancer and revision of clinical guidelines, and provides a source of decision making for medical management and medical insurance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- mid-low rectal cancer patients
Key inclusion criteria (2 listed)
- pathologically confirmed rectal adenocarcinoma
- located within 12cm below the anal verge
Key exclusion criteria (4 listed)
- diagnosed with distant metastasis
- multiple primary colorectal cancers
- history of previous malignant tumors
- Pregnant or lactating women
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 |
|---|---|---|
| Registry study, no specific interventionRegistry study, no specific intervention | Other | – |
Primary outcome
3-year OS
Time frame: 3 years
3-year overall survival
10 secondary outcomes
3-year DFS
Time frame: 3 years
3-year LR
Time frame: 3 years
3-year distant metastasis rate
Time frame: 3 years
neoadjuvant therapy rate
Time frame: at the time point of surgery of the primary lesion
adjuvant therapy rate
Time frame: at the time point of 3-year follow up
EUS/MRI assessment rate
Time frame: at the time point of surgery of the primary lesion
R0 resection rate
Time frame: at the time point of surgery of the primary lesion
CCR
Time frame: immediately after the completion of neoadjuvant therapy assessment
pCR
Time frame: immediately after the completion of surgery
30-day mortality
Time frame: 30 days after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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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.
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 Rectal Neoplasms, run by Peking Union Medical College Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 28 Aug 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Xiao, Professor (+86 13366036387, Xiaoy@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year OS (time frame: 3 years). 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 28 Aug 2023.