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Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.
According to postoperative pathological examination results, all participants will be divided into two groups: complete response (ypT0N0) and poor response (>ypT1-2N0). Differentially expressed genes between complete response and poor response will be analyzed. A scoring formula will be established based on the results. Tumor tissue samples are collected before neoadjuvant therapy and will be analyzed via RNA sequencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparing gene expression differences between poor response group and complete response group by using RNA sequencing. | Using RNA-seq sequencing method to obtain the whole genome transcription profiles of the poor response group and complete response group, and compare the gene expression differences between these two groups. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | The total survival time of the participants from joining the group to the death. If the death time is unknown, the relevant participants will be excluded for analysis. | 3 years |
| Progression Free Survival(PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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All participants will be recruited from Wuhan Union Hospital or Hubei Cancer Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Wang, MD/PhD | Contact | +86 27 85726612 | zhengwang@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zheng Wang, MD/PhD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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Tumor biopsy samples are collected before neoadjuvant therapy when participants undergo colonoscopy or endoscopic ultrasonography. Two pieces of tumor tissue specimens will be extracted. These tissues will be stored at the tumor specimen bank and gene expression profile of these tumor samples will be analyzed using RNA sequencing.
The time period that from participants joining the groups to the progression of disease(recurrence or metastasis) or death of any cause.
| 3 years |
| Hubei Cancer Hospital | Not yet recruiting | Wuhan | Hubei | 430079 | China |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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