Predicting the Efficacy and Prognosis of Rectal Cancer Patients Based on ctDNA-MRD Technology

NCT05969938 | Unknown

• 1 other identifier: B2023-239-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the performance of MRD monitoring in predicting the efficacy and prognosis of neoadjuvant therapy in patients with rectal cancer, and to explore the value of MRD detection in evaluating the prognosis of patients. In this prospective study, 50 patients with stage II-III rectal cancer who are planing to receive neoadjuvant chemoradiotherapy will be enrolled. The tumor tissue will be collected by colonoscopy before treatment and blood samples will be collected before treatment and during treatment.The whole blood samples will receive MRD detection. The change rate and clearance rate of MRD during treatment will be calculated, and will be associated with imaging efficacy evaluation, pathological efficacy evaluation,and prognosis, to determine the performance of MRD in predicting and judging the efficacy of neoadjuvant chemoradiotherapy and postoperative recurrence of rectal cancer.

Conditions

Rectal Adenocarcinoma; Circulating Tumor DNA; Minimal Residual Disease; Neoadjuvant Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Area under the ROC curve (AUC) of the MRD biomarker

  The area under the ROC curve ( AUC ) of MRD

  Baseline to 12 months

Secondary Outcomes (2)

• Local recurrence-free survival（LRFS）

  From date of radical surgery to local recurrence or death due to disease progression，assessed up to 60 months.

• Distant metastases-free survival（DMFS）

  From date of the beginning of neoadjuvant chemoradiotherapy to disease metastasis or death due to any cause,assessed up to 60 months.

Study Arms (1)

Treatment group

A total of 50 patients with stage II-III rectal cancer who plan to receive neoadjuvant chemoradiotherapy between the ages of 18-75 years old, and these patients have no distant metastasis, normal main organ function, and can receive long-term follow-up. simultaneously, these patients are required to provide sufficient ' colonoscopy collection ' tumor tissue samples for MRD customization, and sufficient whole blood samples are required for baseline MRD detection.

Diagnostic Test: MRD detection

Interventions

MRD detection DIAGNOSTIC_TEST

Peripheral blood samples were collected for MRD detection before neoadjuvant chemoradiotherapy, during neoadjuvant chemoradiotherapy, and 3-4 weeks after radical surgery. For patients who achieved cCR after neoadjuvant therapy and adopted the W \& W strategy, the sampling time point was 3 months after the start of watching and waiting.

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study intends to include 50 patients with stage II-III rectal cancer who plan to receive neoadjuvant chemoradiotherapy between the ages of 18-75 years old.

You may qualify if:

• Age 18-75
• Rectal adenocarcinoma confirmed by pathology
• The clinical stage is II-III.
• Neoadjuvant chemoradiotherapy + radical surgery is planned ( cCR patients can choose to wait for observation ).
• ECOG 0-1;
• No distant metastasis ;
• Main organ function is normal ;
• signed informed consent and willing to accept long-term follow-up；
• No anti-tumor treatment was received within 4 weeks before baseline sampling ;
• Adequate ' colonoscopy ' tumor tissue samples can be provided for MRD customization, and sufficient whole blood samples need to be provided for baseline MRD detection.

You may not qualify if:

• unable to provide sufficient tissue / blood samples to meet the research needs ;
• received radiotherapy, chemotherapy, or other targeted or immunotherapy before enrollment ;
• Patients did not receive neoadjuvant therapy according to the original plan ;
• Patients refused to accept genetic testing. -

Sponsors & Collaborators

• WeiWei Xiao: lead
• Haplox Biotechnology Co., Ltd.: collaborator

Study Sites (1)

WeiWei Xiao

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (5)

• Yang Y, Xu H, Chen G, Pan Y. Stratified Prognostic Value of Pathological Response to Preoperative Treatment in yp II/III Rectal Cancer. Front Oncol. 2021 Dec 16;11:795137. doi: 10.3389/fonc.2021.795137. eCollection 2021.

  PMID: 34976836 BACKGROUND

• Scholer LV, Reinert T, Orntoft MW, Kassentoft CG, Arnadottir SS, Vang S, Nordentoft I, Knudsen M, Lamy P, Andreasen D, Mortensen FV, Knudsen AR, Stribolt K, Sivesgaard K, Mouritzen P, Nielsen HJ, Laurberg S, Orntoft TF, Andersen CL. Clinical Implications of Monitoring Circulating Tumor DNA in Patients with Colorectal Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5437-5445. doi: 10.1158/1078-0432.CCR-17-0510. Epub 2017 Jun 9.

  PMID: 28600478 BACKGROUND

• Zhou J, Wang C, Lin G, Xiao Y, Jia W, Xiao G, Liu Q, Wu B, Wu A, Qiu H, Zhang F, Hu K, Xue H, Shen Z, Wang Z, Han J, Niu B, Xu Y, Yu Z, Yang L. Serial Circulating Tumor DNA in Predicting and Monitoring the Effect of Neoadjuvant Chemoradiotherapy in Patients with Rectal Cancer: A Prospective Multicenter Study. Clin Cancer Res. 2021 Jan 1;27(1):301-310. doi: 10.1158/1078-0432.CCR-20-2299. Epub 2020 Oct 12.

  PMID: 33046514 BACKGROUND

• Pazdirek F, Minarik M, Benesova L, Halkova T, Belsanova B, Macek M, Stepanek L, Hoch J. Monitoring of Early Changes of Circulating Tumor DNA in the Plasma of Rectal Cancer Patients Receiving Neoadjuvant Concomitant Chemoradiotherapy: Evaluation for Prognosis and Prediction of Therapeutic Response. Front Oncol. 2020 Jul 24;10:1028. doi: 10.3389/fonc.2020.01028. eCollection 2020.

  PMID: 32793464 BACKGROUND

• Wang Y, Yang L, Bao H, Fan X, Xia F, Wan J, Shen L, Guan Y, Bao H, Wu X, Xu Y, Shao Y, Sun Y, Tong T, Li X, Xu Y, Cai S, Zhu J, Zhang Z. Utility of ctDNA in predicting response to neoadjuvant chemoradiotherapy and prognosis assessment in locally advanced rectal cancer: A prospective cohort study. PLoS Med. 2021 Aug 31;18(8):e1003741. doi: 10.1371/journal.pmed.1003741. eCollection 2021 Aug.

  PMID: 34464382 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The samples including two kinds :1.We will collect tumor tissue samples for WES detection and customized panel.2. We will collect peripheral blood samples for MRD detection.

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

WeiWei Xiao

CONTACT

8613710390520; xiaoww@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sun Yat-sen University

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 1, 2023
• Study Start: June 21, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)