Predicting outcomes in rectal cancer patients using ctDNA technology
Predicting the Efficacy and Prognosis of Rectal Cancer Patients Receiving Neoadjuvant Chemoradiotherapy Based on Circulating Tumor DNA-minimal Residual Disease Technology : A Prospective, Observational Study
Sun Yat-sen University · NCT05969938
This study is testing if monitoring a specific blood marker can help predict how well treatment works and the chances of cancer coming back in people with stage II-III rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05969938 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of minimal residual disease (MRD) monitoring in predicting the efficacy and prognosis of neoadjuvant therapy in patients with stage II-III rectal cancer. It will enroll 50 patients who will undergo tumor tissue collection via colonoscopy and blood sample collection before and during treatment. The study will analyze changes in MRD levels in relation to imaging and pathological evaluations to assess treatment efficacy and the risk of postoperative recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with newly diagnosed stage II-III rectal adenocarcinoma planning to receive neoadjuvant chemoradiotherapy.
Not a fit: Patients with distant metastasis or those who have received prior anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate method for predicting treatment outcomes and recurrence in rectal cancer patients.
How similar studies have performed: While MRD monitoring has shown promise in other cancer types, this specific application in rectal cancer is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age 18-75
2. Rectal adenocarcinoma confirmed by pathology
3. The clinical stage is II-III.
4. Neoadjuvant chemoradiotherapy + radical surgery is planned ( cCR patients can choose to wait for observation ).
5. ECOG 0-1;
6. No distant metastasis ;
7. Main organ function is normal ;
8. signed informed consent and willing to accept long-term follow-up；
9. No anti-tumor treatment was received within 4 weeks before baseline sampling ;
10. Adequate ' colonoscopy ' tumor tissue samples can be provided for MRD customization, and sufficient whole blood samples need to be provided for baseline MRD detection.
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Exclusion Criteria:
1. unable to provide sufficient tissue / blood samples to meet the research needs ;
2. received radiotherapy, chemotherapy, or other targeted or immunotherapy before enrollment ;
3. Patients did not receive neoadjuvant therapy according to the original plan ;
4. Patients refused to accept genetic testing. -
Where this trial is running
Guangzhou, Guangdong
- WeiWei Xiao — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: WeiWei Xiao
- Email: xiaoww@sysucc.org.cn
- Phone: 8613710390520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Adenocarcinoma, Circulating Tumor DNA, Minimal Residual Disease, Neoadjuvant Chemoradiotherapy