ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
Overview
This is a prospective observational study with three primary objectives: Objective 1: Evaluate the detection rate and changes in circulating tumor DNA (ctDNA) levels in blood samples from colorectal cancer patients before, during, and after total neoadjuvant therapy (TNT). Determine the detection rate and change of CtDNA in blood samples of cancer patients before, during, and after TNT then assess changes in ctDNA expression within the study population during treatment. * Determine the ctDNA positivity rate before treatment. * Determine the ctDNA positivity rate during TNT. * Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment. Objective 2: Investigate the relationship between ctDNA expression and MRI/CT scan imaging with the pathological complete response (pCR) to neoadjuvant therapy : * Correlation between ctDNA detection and pCR/TRG/NAR score. Calculate the Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA, * Correlation between MRI/CT scan imaging and pCR. Calculate the PPV and NPV of MRI/CT scan * Combination of ctDNA detection and MRI/CT scan imaging to predict pCR. Calculate the PPV and NPV of the combined markers. Objective 3: Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients.
Detailed description
This is a prospective observational study conducted at the Medical Genetics Institute (MGI), in collaboration with 3 hospitals (175 Military Hospital, Nguyen Tri Phuong Hospital, and 108 Military Central Hospital). Participants must meet all inclusion criteria and no exclusion criteria (detailed in the eligibility section).
Sample Collection
* 10 mL of peripheral blood (Streck tubes) is collected for ctDNA analysis at 3 time points: pre-TNT (at diagnosis), middle of treatment (after chemoradiotherapy or after chemotherapy), and post-TNT (before surgery). * 6-8 slides (6um thickness/slide) of FFPE biopsy tumor samples before treatment * 6-8 slides (6um thickness/slide) of FFPE tumor samples collected after surgery. This sample is used to compare the mutational profiles with the corresponding biopsy samples.
Clinical results for collection
* Age, sex, medical history * Number, size, and stage (TNM) of tumor * MRI and/or CT scan images and reports at pre-treatment, mid-treatment, and end-treatment (before surgery) * Histopathological evaluation of biopsy and surgery tissues, and conclusion of pathological response
* TNM classification, pCR conclusion * TRG conclusion * Disease-free survival follow-up for 2 years
Primary outcome measures
- To investigate the detection rate and change of ctDNA in blood samples of rectal cancer patients during total neoadjuvant therapy [Time frame: 12 months]
- To investigate the relationship between ctDNA expression and MRI/CT scan imaging with pCR response in total neoadjuvant therapy (TNT) [Time frame: 6 months]
- Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients in 2 years [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 18 years and older, both genders
- Patients are diagnosed with stage II-III rectal cancer and indicated for total neoadjuvant therapy
- Biopsy FFPE sample is available at the time of diagnosis
- Patients consented to participate in the study
Exclusion criteria
- Stage I rectal cancer, recurrent or metastatic cancer
- Other cancer metastasis to the rectum
- Patients are indicated for chemoradiation therapy only
- Have been or are being treated for cancer
- Patients do not agree to participate in the studies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Vietnam · 1 center
- Medical Genetics Institute — Ho Chi Minh City
Publications
- Kim MJ, Lee DW, Kang HC, Park JW, Ryoo SB, Han SW, Kim KS, Chie EK, Oh JH, Jeong WK, Kim BH, Nam EM, Jeong SY. Total neoadjuvant therapy with short-course radiotherapy Versus long-course neoadjuvant chemoradiotherapy in Locally Advanced Rectal cancer, Korean trial (TV-LARK trial): study protocol of a multicentre randomized controlled trial. BMC Cancer. 2023 Aug 8;23(1):734. doi: 10.1186/s12885-023 PMID 37553666
- Johnson GGRJ, Park J, Helewa RM, Goldenberg BA, Nashed M, Hyun E. Total neoadjuvant therapy for rectal cancer: a guide for surgeons. Can J Surg. 2023 Apr 21;66(2):E196-E201. doi: 10.1503/cjs.005822. Print 2023 Mar-Apr. PMID 37085291
- Lopez-Campos F, Martin-Martin M, Fornell-Perez R, Garcia-Perez JC, Die-Trill J, Fuentes-Mateos R, Lopez-Duran S, Dominguez-Rullan J, Ferreiro R, Riquelme-Oliveira A, Hervas-Moron A, Counago F. Watch and wait approach in rectal cancer: Current controversies and future directions. World J Gastroenterol. 2020 Aug 7;26(29):4218-4239. doi: 10.3748/wjg.v26.i29.4218. PMID 32848330
- Li LH, Chen ZF, Wang XF, Liu X, Jiang WZ, Zhuo SM, Jiang LW, Guan GX, Chen JX. Monitoring neoadjuvant therapy responses in rectal cancer using multimodal nonlinear optical microscopy. Oncotarget. 2017 Nov 3;8(63):107323-107333. doi: 10.18632/oncotarget.22366. eCollection 2017 Dec 5. PMID 29291032
- Feeney G, Sehgal R, Sheehan M, Hogan A, Regan M, Joyce M, Kerin M. Neoadjuvant radiotherapy for rectal cancer management. World J Gastroenterol. 2019 Sep 7;25(33):4850-4869. doi: 10.3748/wjg.v25.i33.4850. PMID 31543678
- Glynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rodel C, Cervantes A, Arnold D; ESMO Guidelines Committee. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv22-iv40. doi: 10.1093/annonc/mdx224. No abstract available. PMID 28881920
- Hu H, Huang J, Lan P, Wang L, Huang M, Wang J, Deng Y. CEA clearance pattern as a predictor of tumor response to neoadjuvant treatment in rectal cancer: a post-hoc analysis of FOWARC trial. BMC Cancer. 2018 Nov 20;18(1):1145. doi: 10.1186/s12885-018-4997-y. PMID 30458734
- Yan YY, Guo QR, Wang FH, Adhikari R, Zhu ZY, Zhang HY, Zhou WM, Yu H, Li JQ, Zhang JY. Cell-Free DNA: Hope and Potential Application in Cancer. Front Cell Dev Biol. 2021 Feb 22;9:639233. doi: 10.3389/fcell.2021.639233. eCollection 2021. PMID 33693004
Identifiers
NCT: NCT06589388 · GS_ZTR