Rectal CancerBIOPSYNCT04743102
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer
A study testing multi-points and full-thickness Biopsy and traditional cCR in people with Rectal Cancer and Neoadjuvant Therapy, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Neoadjuvant Therapy, Complete Remission
- What is being tested?
- multi-points and full-thickness Biopsy and traditional cCR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2028
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female, between 18 and 80 years old;
- Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma;
- The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm;
- The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
- Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis;
- CCR patients evaluated after neoadjuvant therapy (no mass or ulcer found on digital rectal examination;Endoscopic examination showed no other changes except flat scar, telangiectasia or pallor of mucosa.MRI or rectal ultrasound showed no residual tumor in the primary site and lymphatic drainage area.Serum carcinoembryonic antigen (CEA) was normal.
- Signing informed consent for surgery.
Who cannot join
- Previous history of malignant colorectal tumor;
- Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
- Unresectable lymph node metastasis;
- Recently diagnosed with other malignant tumors;
- Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
- ASA rating ≥IV and/or ECOG physical status score ≥2 points;
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- Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery;
- a history of serious mental illness;
- pregnant or lactating women;
- Those with uncontrolled infection;
- Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study
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
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Jiagang Han, 86-0-13522867841, hjg211@163.com
Zhenjun Wang
About this study
Official title: Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer
Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.
- Conditions
- Rectal Cancer, Neoadjuvant Therapy, Complete Remission, Metastasis
- Being tested
- multi-points and full-thickness Biopsy, traditional cCR
- Keywords
- rectal cancer, neoadjuvant therapy, clinical complete remission, full-thickness biopsy, watch-and wait, regrowth
- Medical subject headings
- Rectal Neoplasms, Pathologic Complete Response, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-points and full-thickness BiopsyProcedure or surgery
Four points around the tumor site and center of the tumor site full-thickness Biopsy
traditional cCRDiagnostic test
diginal examination, endoscopy test, rectal MRI, and serum CEA level
| Study group | Role | What they receive |
|---|---|---|
| Biopsy cCR | Experimental | Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, we add multi-points and full-thickness Biopsy to further improve the accuracy of cCR after neoadjuvant therapy for rectal cancer. Receives: Procedure: multi-points and full-thickness Biopsy |
| Conventional cCR | Active comparator | Based on digital examination, serum CEA level, rectal MRI, endoscopy presentation, to study accuracy of cCR after neoadjuvant therapy for rectal cancer. Receives: Diagnostic Test: traditional cCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response rate
Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer
Measured: 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer
pathological complete remission
No tumor cell found in surgical specimens
Measured: 2 weeks after patients received radical operation
Secondary outcomes (2)
Disease Free Survival
no tumor regrowth or recurrence or metastasis found
Measured: 5 years after operation or "watch and wait" approach
Overall Survival
survive during following
Measured: 5 years after operation or "watch and wait" approach
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
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 Beijing Chao Yang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Zhenjun Wang, Study chair, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743102
- Sponsor's protocol ID
- BIOPSY-01
- Acronym
- BIOPSY
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer
- ClinicalTrials.gov ID
- NCT04743102
- Acronym / sponsor ID
- BIOPSY / BIOPSY-01
- Conditions
- Rectal Cancer, Neoadjuvant Therapy, Complete Remission, Metastasis
- Keywords
- rectal cancer, neoadjuvant therapy, clinical complete remission, full-thickness biopsy, watch-and wait, regrowth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Feb 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.
Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biopsy cCR | Experimental | Procedure: multi-points and full-thickness BiopsyBased on digital examination, serum CEA level, rectal MRI, endoscopy presentation, we add multi-points and full-thickness Biopsy to further improve the accuracy of cCR after neoadjuvant therapy for rectal cancer. |
| Conventional cCR | Active comparator | Diagnostic Test: traditional cCRBased on digital examination, serum CEA level, rectal MRI, endoscopy presentation, to study accuracy of cCR after neoadjuvant therapy for rectal cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult male and female, between 18 and 80 years old;
- Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma;
- The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm;
- The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
- Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis;
Key exclusion criteria (11 listed)
- Previous history of malignant colorectal tumor;
- Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
- Unresectable lymph node metastasis;
- Recently diagnosed with other malignant tumors;
- Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
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 |
|---|---|---|
| multi-points and full-thickness BiopsyFour points around the tumor site and center of the tumor site full-thickness Biopsy | Procedure or surgery | Biopsy cCR |
| traditional cCRdiginal examination, endoscopy test, rectal MRI, and serum CEA level | Diagnostic test | Conventional cCR |
Primary outcome
Clinical Complete Response rate
Time frame: 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer
Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer
pathological complete remission
Time frame: 2 weeks after patients received radical operation
No tumor cell found in surgical specimens
2 secondary outcomes
Disease Free Survival
Time frame: 5 years after operation or "watch and wait" approach
Overall Survival
Time frame: 5 years after operation or "watch and wait" approach
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 21 Feb 2023.
- 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.
Zhenjun Wang study chair
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-points and full-thickness Biopsy and traditional cCR in people with Rectal Cancer and Neoadjuvant Therapy, run by Beijing Chao Yang 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 7 inclusion and 11 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 21 Feb 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 Jiagang Han (86-10-85231604, hanjiagang@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Complete Response rate (time frame: 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer). The study lists 2 primary outcomes in all. 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 21 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.