Rectal CancerNCT03573791
Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer
An observational study of Rectal Cancer and Cancer of Rectum, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Cancer of Rectum, Cancer of the Rectum
- How many people
- 152 participants
- Where
- 2 sitesChina
- Study dates
- 21 May 2018to 21 May 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants will be recruited from Wuhan Union Hospital or Hubei Cancer Hospital.
Who may be able to join
- Histopathology proved to be adenocarcinoma of the rectum.
- 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.
Who cannot join
- With intestinal obstruction or impending obstruction, or perforation.
- With other malignancies occurred within 5 years.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Zheng Wang, MD/PhD, +86 27 85726612, zhengwang@hust.edu.cn
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Shengwei Ye, MD/PhD
About this study
Official title: Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.
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.
Read the detailed description
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.
- Conditions
- Rectal Cancer, Cancer of Rectum, Cancer of the Rectum, Neoplasms, Rectal, Rectal Tumors, Rectum Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 3 years
Progression Free Survival(PFS)
The time period that from participants joining the groups to the progression of disease(recurrence or metastasis) or death of any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start21 May 2018
- Primary completion21 May 2027 (estimated)
- Study completion21 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Wang, MD/PhD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Zheng Wang, MD/PhD, Study chair, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573791
- Sponsor's protocol ID
- WHUHGE-R01
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2018
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.
- ClinicalTrials.gov ID
- NCT03573791
- Acronym / sponsor ID
- WHUHGE-R01
- Conditions
- Rectal Cancer, Cancer of Rectum, Cancer of the Rectum, Neoplasms, Rectal, Rectal Tumors, Rectum Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 21 May 2027 (estimated)
- Study completion
- 21 May 2028 (estimated)
- First posted
- 29 Jun 2018 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be recruited from Wuhan Union Hospital or Hubei Cancer Hospital.
Key inclusion criteria (5 listed)
- Histopathology proved to be adenocarcinoma of the rectum.
- 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.
Key exclusion criteria (2 listed)
- With intestinal obstruction or impending obstruction, or perforation.
- With other malignancies occurred within 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparing gene expression differences between poor response group and complete response group by using RNA sequencing.
Time frame: 6 months
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.
2 secondary outcomes
Overall survival(OS)
Time frame: 3 years
Progression Free Survival(PFS)
Time frame: 3 years
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 18 Aug 2026.
- BackgroundChang 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.
- 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.
Zheng Wang, MD/PhD study chair
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
2 sites 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 and Cancer of Rectum, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites 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 5 inclusion and 2 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Zheng Wang, MD/PhD (+86 27 85726612, zhengwang@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing gene expression differences between poor response group and complete response group by using RNA sequencing. (time frame: 6 months). 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 NCT03573791, which also lists 1 linked publication.
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 18 Aug 2026.