Rectal CancerNCT04850027
MRI-guided Lateral Lymph Node Dissection in Rectal Cancer
An observational study of Rectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- TME+Lateral lymph node dissection.
- Type of treatment
- Surgery or procedure
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2025
- How long will I take part?
- 3 Years
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lower rectal cancer patients with lateral lymph node short diameter ≥ 5 mm were included in the study. TME with lateral lymph node dissection was performed in these patients. LLN positive rate, local recurrence rate, 3-year overall survival rate, perioperative complication rate and quality of life were documented and analysed.
Who may be able to join
- Age between 18-75 years old
- Pathologically confirmed as rectal adenocarcinoma
- The tumor is located in the middle or lower rectum
- Preoperative MRI assessment is T2-4 N+M0
- Lateral lymph node short diameter ≥ 5 mm (MRI)
- Signed informed consent
Who cannot join
- Previous history of malignant colorectal tumors
- Multiple abdominal or pelvic surgeries were performed
- Complicated with bowel obstruction, perforation or bleeding
- Patients undergoing palliative surgery
- Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery
- Have a history of severe mental illness
- Pregnant or breastfeeding women （8) Patients previously treated with iliac artery surgery (or its branches)
- R0 resection cannot complete (10) ASA grade ≥ IV
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality, 100021
Qian Liu, M.D, 01087787110, fcwpumch@163.com
Zheng Liu, M.D, 01087787111, 190977026@qq.com
About this study
Official title: MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)
To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI
Read the detailed description
Our study design is a multicenter, prospective, registry study.
We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm.
The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 ~ 50.5 Gy are recommended.
The postoperative examination should be performed every three months in the first two years and every six months in the following three years.
Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.
- Conditions
- Rectal Cancer
- Being tested
- TME+Lateral lymph node dissection.
- Keywords
- Lateral lymph node, Surgery, Magnetic resonance imaging, oncological outcome
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TME+Lateral lymph node dissection.Procedure or surgery
TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.
| Study group | Role | What they receive |
|---|---|---|
| Lower rectal cancer patients with a LLN ≥ 5mm | Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included. Receives: Procedure: TME+Lateral lymph node dissection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological positive rate
The proportion of patients with positive lateral lymph node which was confirmed pathologically.
Measured: 3-year.
Local recurrence rate
The proportion of patients with local recurrence after 3 years of surgery
Measured: 3-year
Overall survival rate
The proportion of patients survived after 3 years of surgery
Measured: 3-year
Disease free survival
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery.
Measured: 3-year
Secondary outcomes (3)
Early morbidity rate
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
Measured: 30 days
Duration of the surgery
The duration of time between the start and the end of the surgery.
Measured: 1 day
Postoperative complications
Complications occurring within 30 days after surgery, mainly urinary and sexual functions.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 268 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shengjing Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, West China Hospital, The First Affiliated Hospital of Dalian Medical University, China-Japan Friendship Hospital, Peking University First Hospital, Beijing Friendship Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Cancer Hospital & Institute, The First Hospital of Jilin University, China-Japan Union Hospital, Jilin University, Tianjin People's Hospital, Second Affiliated Hospital of Suzhou University, Peking Union Medical College Hospital, Ruijin Hospital, First Hospital of China Medical University, Chinese PLA General Hospital, Zhejiang Cancer Hospital, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Hospital of Qingdao University, Shanghai Cancer Hospital, China
- Responsible party
- Sponsor
- Investigators
- Qian Liu, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850027
- Sponsor's protocol ID
- MALAREC
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data are available from Qian Liu upon request.
Publications
Baik SH, Kim NK, Lee YC, Kim H, Lee KY, Sohn SK, Cho CH. Prognostic significance of circumferential resection margin following total mesorectal excision and adjuvant chemoradiotherapy in patients with rectal cancer. Ann Surg Oncol. 2007 Feb;14(2):462-9. doi: 10.1245/s10434-006-9171-0. Epub 2006 Nov 10.
PubMed 17096053Akiyoshi T, Ueno M, Matsueda K, Konishi T, Fujimoto Y, Nagayama S, Fukunaga Y, Unno T, Kano A, Kuroyanagi H, Oya M, Yamaguchi T, Watanabe T, Muto T. Selective lateral pelvic lymph node dissection in patients with advanced low rectal cancer treated with preoperative chemoradiotherapy based on pretreatment imaging. Ann Surg Oncol. 2014 Jan;21(1):189-96. doi: 10.1245/s10434-013-3216-y. Epub 2013 Aug 21.
PubMed 23963871Fujita S, Mizusawa J, Kanemitsu Y, Ito M, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Bandou H, Katsumata K, Murata K, Akagi Y, Takiguchi N, Saida Y, Nakamura K, Fukuda H, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial. Ann Surg. 2017 Aug;266(2):201-207. doi: 10.1097/SLA.0000000000002212.
PubMed 28288057Ishihara S, Kawai K, Tanaka T, Kiyomatsu T, Hata K, Nozawa H, Morikawa T, Watanabe T. Oncological Outcomes of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer Treated With Preoperative Chemoradiotherapy. Dis Colon Rectum. 2017 May;60(5):469-476. doi: 10.1097/DCR.0000000000000752.
PubMed 28383446Furuhata T, Okita K, Nishidate T, Ito T, Yamaguchi H, Ueki T, Akizuki E, Meguro M, Ogawa T, Kukita K, Kimura Y, Mizuguchi T, Hirata K. Clinical feasibility of laparoscopic lateral pelvic lymph node dissection following total mesorectal excision for advanced rectal cancer. Surg Today. 2015 Mar;45(3):310-4. doi: 10.1007/s00595-014-0906-4. Epub 2014 May 3.
PubMed 24792010Huang F, Wei R, Zhou S, Mei S, Xiao T, Xing W, Liu Q; the Chinese Lateral Node Collaborative Group. The diagnosis and oncological outcomes of obturator and internal iliac lymph node metastasis in middle-low rectal cancer: results of a multicenter Lateral Node Collaborative Group study in China. Discov Oncol. 2024 Nov 4;15(1):618. doi: 10.1007/s12672-024-01500-4.
PubMed 39497010Tang B, Zhou S, He K, Mei S, Qiu W, Guan X, Liu F, Chi C, Wang X, Tian J, Liu Q, Tang J. Applications of Near-Infrared Fluorescence Imaging and Angiography of Inferior Vesical Artery in Laparoscopic Lateral Lymph Node Dissection: A Prospective Nonrandomized Controlled Study. Dis Colon Rectum. 2024 Jan 1;67(1):175-184. doi: 10.1097/DCR.0000000000002926. Epub 2023 Aug 30.
PubMed 38091416Zhou S, Zhang H, Liang J, Fu W, Lou Z, Feng B, Yang Y, Xie Z, Liu Q; Chinese Lateral Node Collaborative Group. Feasibility, Indications, and Prognostic Significance of Selective Lateral Pelvic Lymph Node Dissection After Preoperative Chemoradiotherapy in Middle/Low Rectal Cancer: Results of a Multicenter Lateral Node Study in China. Dis Colon Rectum. 2024 Feb 1;67(2):228-239. doi: 10.1097/DCR.0000000000002640. Epub 2023 Jan 4.
PubMed 36649192Zhou S, Mei S, Feng B, Yang Y, Wang X, Wang Q, Liu Q. Feasibility and safety of lateral pelvic lymph node dissection for elderly patients with middle-low rectal cancer: results of a large multicenter lateral node collaborative group study in China. Tech Coloproctol. 2023 Aug;27(8):655-664. doi: 10.1007/s10151-022-02746-2. Epub 2022 Dec 14.
PubMed 36515808Zhou S, Tang J, Liang J, Lou Z, Fu W, Feng B, Yang Y, Xiao Y, Liu Q. Effective dissecting range and prognostic significance of lateral pelvic lymph node dissection for middle-low rectal cancer patients with lateral pelvic lymph node metastasis: Results of a large multicenter lateral node collaborative group in China. Front Oncol. 2022 Aug 12;12:916285. doi: 10.3389/fonc.2022.916285. eCollection 2022.
PubMed 36033473Zhou S, Song Y, Xie Y, Liu Q. Neoadjuvant Chemoradiotherapy Prior to Lateral Lymph Node Dissection in Rectal Cancer with Suspected Lateral Lymph Node Metastasis: a Multicenter Lateral Node Study in China. J Gastrointest Surg. 2023 Jan;27(1):158-161. doi: 10.1007/s11605-022-05425-7. Epub 2022 Jul 26. No abstract available.
PubMed 35882759
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)
- ClinicalTrials.gov ID
- NCT04850027
- Acronym / sponsor ID
- MALAREC
- Conditions
- Rectal Cancer
- Keywords
- Lateral lymph node, Surgery, Magnetic resonance imaging, oncological outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Shengjing Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, West China Hospital, The First Affiliated Hospital of Dalian Medical University, China-Japan Friendship Hospital, Peking University First Hospital, Beijing Friendship Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Cancer Hospital & Institute, The First Hospital of Jilin University, China-Japan Union Hospital, Jilin University, Tianjin People's Hospital, Second Affiliated Hospital of Suzhou University, Peking Union Medical College Hospital, Ruijin Hospital, First Hospital of China Medical University, Chinese PLA General Hospital, Zhejiang Cancer Hospital, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Hospital of Qingdao University, Shanghai Cancer Hospital, China
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Apr 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.
To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI
Detailed description
Our study design is a multicenter, prospective, registry study.
We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm.
The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 ~ 50.5 Gy are recommended.
The postoperative examination should be performed every three months in the first two years and every six months in the following three years.
Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower rectal cancer patients with a LLN ≥ 5mm | – | Procedure: TME+Lateral lymph node dissection.Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lower rectal cancer patients with lateral lymph node short diameter ≥ 5 mm were included in the study. TME with lateral lymph node dissection was performed in these patients. LLN positive rate, local recurrence rate, 3-year overall survival rate, perioperative complication rate and quality of life were documented and analysed.
Key inclusion criteria (6 listed)
- Age between 18-75 years old
- Pathologically confirmed as rectal adenocarcinoma
- The tumor is located in the middle or lower rectum
- Preoperative MRI assessment is T2-4 N+M0
- Lateral lymph node short diameter ≥ 5 mm (MRI)
Key exclusion criteria (8 listed)
- Previous history of malignant colorectal tumors
- Multiple abdominal or pelvic surgeries were performed
- Complicated with bowel obstruction, perforation or bleeding
- Patients undergoing palliative surgery
- Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery
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 |
|---|---|---|
| TME+Lateral lymph node dissection.TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm. | Procedure or surgery | Lower rectal cancer patients with a LLN ≥ 5mm |
Primary outcome
Pathological positive rate
Time frame: 3-year.
The proportion of patients with positive lateral lymph node which was confirmed pathologically.
Local recurrence rate
Time frame: 3-year
The proportion of patients with local recurrence after 3 years of surgery
Overall survival rate
Time frame: 3-year
The proportion of patients survived after 3 years of surgery
Disease free survival
Time frame: 3-year
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery.
3 secondary outcomes
Early morbidity rate
Time frame: 30 days
Duration of the surgery
Time frame: 1 day
Postoperative complications
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Background: PubMed 17096053Baik SH, Kim NK, Lee YC, Kim H, Lee KY, Sohn SK, Cho CH. Prognostic significance of circumferential resection margin following total mesorectal excision and adjuvant chemoradiotherapy in patients with rectal cancer. Ann Surg Oncol. 2007 Feb;14(2):462-9. doi: 10.1245/s10434-006-9171-0. Epub 2006 Nov 10.
- Background: PubMed 23963871Akiyoshi T, Ueno M, Matsueda K, Konishi T, Fujimoto Y, Nagayama S, Fukunaga Y, Unno T, Kano A, Kuroyanagi H, Oya M, Yamaguchi T, Watanabe T, Muto T. Selective lateral pelvic lymph node dissection in patients with advanced low rectal cancer treated with preoperative chemoradiotherapy based on pretreatment imaging. Ann Surg Oncol. 2014 Jan;21(1):189-96. doi: 10.1245/s10434-013-3216-y. Epub 2013 Aug 21.
- Background: PubMed 28288057Fujita S, Mizusawa J, Kanemitsu Y, Ito M, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Bandou H, Katsumata K, Murata K, Akagi Y, Takiguchi N, Saida Y, Nakamura K, Fukuda H, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial. Ann Surg. 2017 Aug;266(2):201-207. doi: 10.1097/SLA.0000000000002212.
- Background: PubMed 28383446Ishihara S, Kawai K, Tanaka T, Kiyomatsu T, Hata K, Nozawa H, Morikawa T, Watanabe T. Oncological Outcomes of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer Treated With Preoperative Chemoradiotherapy. Dis Colon Rectum. 2017 May;60(5):469-476. doi: 10.1097/DCR.0000000000000752.
- Background: PubMed 24792010Furuhata T, Okita K, Nishidate T, Ito T, Yamaguchi H, Ueki T, Akizuki E, Meguro M, Ogawa T, Kukita K, Kimura Y, Mizuguchi T, Hirata K. Clinical feasibility of laparoscopic lateral pelvic lymph node dissection following total mesorectal excision for advanced rectal cancer. Surg Today. 2015 Mar;45(3):310-4. doi: 10.1007/s00595-014-0906-4. Epub 2014 May 3.
- Derived from this study: PubMed 39497010Huang F, Wei R, Zhou S, Mei S, Xiao T, Xing W, Liu Q; the Chinese Lateral Node Collaborative Group. The diagnosis and oncological outcomes of obturator and internal iliac lymph node metastasis in middle-low rectal cancer: results of a multicenter Lateral Node Collaborative Group study in China. Discov Oncol. 2024 Nov 4;15(1):618. doi: 10.1007/s12672-024-01500-4.
- Derived from this study: PubMed 38091416Tang B, Zhou S, He K, Mei S, Qiu W, Guan X, Liu F, Chi C, Wang X, Tian J, Liu Q, Tang J. Applications of Near-Infrared Fluorescence Imaging and Angiography of Inferior Vesical Artery in Laparoscopic Lateral Lymph Node Dissection: A Prospective Nonrandomized Controlled Study. Dis Colon Rectum. 2024 Jan 1;67(1):175-184. doi: 10.1097/DCR.0000000000002926. Epub 2023 Aug 30.
- Derived from this study: PubMed 36649192Zhou S, Zhang H, Liang J, Fu W, Lou Z, Feng B, Yang Y, Xie Z, Liu Q; Chinese Lateral Node Collaborative Group. Feasibility, Indications, and Prognostic Significance of Selective Lateral Pelvic Lymph Node Dissection After Preoperative Chemoradiotherapy in Middle/Low Rectal Cancer: Results of a Multicenter Lateral Node Study in China. Dis Colon Rectum. 2024 Feb 1;67(2):228-239. doi: 10.1097/DCR.0000000000002640. Epub 2023 Jan 4.
- Derived from this study: PubMed 36515808Zhou S, Mei S, Feng B, Yang Y, Wang X, Wang Q, Liu Q. Feasibility and safety of lateral pelvic lymph node dissection for elderly patients with middle-low rectal cancer: results of a large multicenter lateral node collaborative group study in China. Tech Coloproctol. 2023 Aug;27(8):655-664. doi: 10.1007/s10151-022-02746-2. Epub 2022 Dec 14.
- Derived from this study: PubMed 36033473Zhou S, Tang J, Liang J, Lou Z, Fu W, Feng B, Yang Y, Xiao Y, Liu Q. Effective dissecting range and prognostic significance of lateral pelvic lymph node dissection for middle-low rectal cancer patients with lateral pelvic lymph node metastasis: Results of a large multicenter lateral node collaborative group in China. Front Oncol. 2022 Aug 12;12:916285. doi: 10.3389/fonc.2022.916285. eCollection 2022.
- Derived from this study: PubMed 35882759Zhou S, Song Y, Xie Y, Liu Q. Neoadjuvant Chemoradiotherapy Prior to Lateral Lymph Node Dissection in Rectal Cancer with Suspected Lateral Lymph Node Metastasis: a Multicenter Lateral Node Study in China. J Gastrointest Surg. 2023 Jan;27(1):158-161. doi: 10.1007/s11605-022-05425-7. Epub 2022 Jul 26. No abstract available.
- Individual participant dataSharing planned: Yes. The data are available from Qian Liu upon request.
Related trials for Rectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingPhase 2
Exploratory Study of Short-Course Radiotherapy Followed by Adebrelimab Combined With Chemotherapy for Organ Preservation in Locally Advanced Rectal Cancer
Locally Advanced Resectable Rectal Cancer
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
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.
Qian Liu, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Liu, M.D (01087787110, fcwpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological positive rate (time frame: 3-year.). The study lists 4 primary outcomes in all. 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 NCT04850027, which also lists 11 linked publications.
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 26 Apr 2021.