ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
NCT ID: NCT06589388
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-05-21
2027-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Gene Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Sinh D Nguyen, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical Genetics Institude
Locations
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Medical Genetics Institute
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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References
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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/s12885-023-11177-7.
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.
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.
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.
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.
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.
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.
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.
McDuff SGR, Hardiman KM, Ulintz PJ, Parikh AR, Zheng H, Kim DW, Lennerz JK, Hazar-Rethinam M, Van Seventer EE, Fetter IJ, Nadres B, Eyler CE, Ryan DP, Weekes CD, Clark JW, Cusack JC, Goyal L, Zhu AX, Wo JY, Blaszkowsky LS, Allen J, Corcoran RB, Hong TS. Circulating Tumor DNA Predicts Pathologic and Clinical Outcomes Following Neoadjuvant Chemoradiation and Surgery for Patients With Locally Advanced Rectal Cancer. JCO Precis Oncol. 2021 Jan 12;5:PO.20.00220. doi: 10.1200/PO.20.00220. eCollection 2021.
Dizdarevic E, Hansen TF, Jakobsen A. The Prognostic Importance of ctDNA in Rectal Cancer: A Critical Reappraisal. Cancers (Basel). 2022 Apr 30;14(9):2252. doi: 10.3390/cancers14092252.
Nguyen Hoang VA, Nguyen ST, Nguyen TV, Pham TH, Doan PL, Nguyen Thi NT, Nguyen ML, Dinh TC, Pham DH, Nguyen NM, Nguyen DS, Nguyen DQ, Lu YT, Do TTT, Truong DK, Phan MD, Nguyen HN, Giang H, Tu LN. Genetic landscape and personalized tracking of tumor mutations in Vietnamese women with breast cancer. Mol Oncol. 2023 Apr;17(4):598-610. doi: 10.1002/1878-0261.13356. Epub 2023 Jan 15.
Nguyen HT, Nguyen TV, Nguyen Hoang VA, Tran DH, Le Trinh NA, Le MT, Nguyen Tran TA, Pham TH, Dinh TC, Nguyen TS, Nguyen The KC, Mai H, Chu MT, Pham DH, Nguyen XC, Ngo Ha TM, Nguyen DS, Nguyen DQ, Lu YT, Do Thi TT, Truong DK, Nguyen QT, Nguyen HN, Giang H, Tu LN. Tumor genomic profiling and personalized tracking of circulating tumor DNA in Vietnamese colorectal cancer patients. Front Oncol. 2022 Dec 12;12:1069296. doi: 10.3389/fonc.2022.1069296. eCollection 2022.
Other Identifiers
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GS_ZTR
Identifier Type: -
Identifier Source: org_study_id
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