Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
NCT ID: NCT03573791
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
152 participants
OBSERVATIONAL
2018-05-21
2027-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Complete response
After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging ypT0N0 as complete response.
No interventions assigned to this group
Poor response
After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging \>ypT1-2N0 as poor response.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The edge of tumor is within 12cm of anus margin.
* According to the eighth edition of AJCC TNM staging standard ,that staging for Ⅱ-Ⅲ period, as T3-T4, N0 or any T, N1-2.
* There is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy.
* Understand and agree to sign the informed consent for the study.
Exclusion Criteria
* With other malignancies occurred within 5 years.
18 Years
75 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Zheng Wang, MD/PhD
Study chair, Clinical Professor
Principal Investigators
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Zheng Wang, MD/PhD
Role: STUDY_CHAIR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Wuhan Union Hospital
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Shengwei Ye, MD/PhD
Role: primary
References
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Chang GJ, Park IJ, You YN, et al. Neoadjuvant treatment response and outcomes in locally advanced rectal cancer: Establishing oncologic benchmarks. Journal of Clinical Oncology 29(15):3545-3545,2011.
Other Identifiers
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WHUHGE-R01
Identifier Type: -
Identifier Source: org_study_id
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