The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer

NCT06283875 | Not Yet Recruiting

• 1 other identifier: PROMISEPLUS-301
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS.

Conditions

Ovarian Cancer

Keywords

ctDNA; MRD; cervical carcinoma; operation; Radical radiotherapy and chemotherapy; Efficacy prediction; Recurrence monitoring

Outcome Measures

Primary Outcomes (1)

• DFS of enrolled patients for 2 years

  DFS of enrolled patients for 2 years

  2 years

Study Arms (2)

Surgical treatment queue (N=40)

Cervical cancer patients who meet the inclusion criteria and are eligible for radical surgical resection. Collect surgical tumor tissue samples from the screening stage of patients in this queue, as well as peripheral blood samples (20 ml/time) from baseline, postoperative, postoperative radiotherapy and chemotherapy end nodes, consolidation treatment end nodes (some patients with this treatment), and multiple nodes during the 6-month follow-up stage. Perform ctDNA MRD testing in a timely manner separately

Radical radiotherapy and chemotherapy treatment cohort (N=40)

Cervical cancer patients who meet the inclusion criteria and are eligible for radical radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the screening phase, as well as peripheral blood samples (20 ml/time) from multiple nodes at baseline, mid-term of curative radiotherapy and chemotherapy, after curative radiotherapy and chemotherapy, after consolidation therapy (if any), and at 6 months/time during the follow-up phase. Perform ctDNA MRD testing in a timely manner separately

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study focuses on newly diagnosed cervical cancer patients who have been confirmed by histology or cytology to undergo surgical resection or curative radiotherapy and chemotherapy in locally advanced stages (stages IB-IV). A total of 80 patients who meet the inclusion criteria and voluntarily sign informed consent forms are planned to be enrolled. According to the curative treatment measures that patients can accept, the enrolled patients are divided into a operable treatment queue (N=40) and a curative radiotherapy and chemotherapy treatment queue (N=40).

You may qualify if:

• (1) Confirmed by histopathology and classified as stage IB-IVA cervical cancer patients according to the 2018 FIGO staging criteria;
• (2) Patients can receive surgical treatment or curative radiotherapy and chemotherapy;
• (3) Age range from 18 to 80 years old;
• (4) General condition: ECOG 0-2;
• (5) At least one measurable lesion (RECIST 1.1 standard);
• (6) Be able to understand the research plan and voluntarily participate in this study, and sign an informed consent form;
• (7) Good compliance, able to cooperate in collecting specimens from various nodes and provide corresponding clinical information;
• (8) Having comprehensive clinical data on imaging and pathology;
• (9) The estimated survival time of the patient is greater than 3 months;
• (10) Having sufficient organ and bone marrow functions.

You may not qualify if:

• \) Within 5 years, suffering from other malignant tumors or metastatic or recurrent cervical cancer;
• (2) Has received any tumor treatment plan in the past;
• (3) Surgical resection or curative radiotherapy and chemotherapy are not acceptable;
• (4) Unable to follow the determined clinical follow-up period in conjunction with the study for follow-up;
• (5) Inability to accept or provide specified efficacy evaluation methods such as CT;
• (6) Suffering from autoimmune diseases;
• (7) Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
• (8) Subjects with any severe and/or uncontrolled diseases;
• (9) According to the researchers judgment, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study by the subjects

Sponsors & Collaborators

• Geneplus-Beijing Co. Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Related Publications (11)

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  PMID: 33113150 BACKGROUND

• Tian J, Geng Y, Lv D, Li P, Cordova M, Liao Y, Tian X, Zhang X, Zhang Q, Zou K, Zhang Y, Zhang X, Li Y, Zhang J, Ma Z, Shao Y, Song L, Owen GI, Li T, Liu R, Liu Q, Zou L, Zhang Z, Li Z. Using plasma cell-free DNA to monitor the chemoradiotherapy course of cervical cancer. Int J Cancer. 2019 Nov 1;145(9):2547-2557. doi: 10.1002/ijc.32295. Epub 2019 Apr 16.

  PMID: 30919951 BACKGROUND

• Pan Y, Zhang JT, Gao X, Chen ZY, Yan B, Tan PX, Yang XR, Gao W, Gong Y, Tian Z, Liu SM, Lin H, Sun H, Huang J, Liu SY, Yan HH, Dong S, Xu CR, Chen HJ, Wang Z, Li P, Guan Y, Wang BC, Yang JJ, Tu HY, Yang XN, Zhong WZ, Xia X, Yi X, Zhou Q, Wu YL. Dynamic circulating tumor DNA during chemoradiotherapy predicts clinical outcomes for locally advanced non-small cell lung cancer patients. Cancer Cell. 2023 Oct 9;41(10):1763-1773.e4. doi: 10.1016/j.ccell.2023.09.007.

  PMID: 37816331 BACKGROUND

• Zhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486.

  PMID: 35543554 BACKGROUND

• Liu T, Yao Q, Jin H. Plasma Circulating Tumor DNA Sequencing Predicts Minimal Residual Disease in Resectable Esophageal Squamous Cell Carcinoma. Front Oncol. 2021 May 20;11:616209. doi: 10.3389/fonc.2021.616209. eCollection 2021.

  PMID: 34094900 BACKGROUND

• Schwarzenbach H, Hoon DS, Pantel K. Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer. 2011 Jun;11(6):426-37. doi: 10.1038/nrc3066. Epub 2011 May 12.

  PMID: 21562580 BACKGROUND

• Azad TD, Chaudhuri AA, Fang P, Qiao Y, Esfahani MS, Chabon JJ, Hamilton EG, Yang YD, Lovejoy A, Newman AM, Kurtz DM, Jin M, Schroers-Martin J, Stehr H, Liu CL, Hui AB, Patel V, Maru D, Lin SH, Alizadeh AA, Diehn M. Circulating Tumor DNA Analysis for Detection of Minimal Residual Disease After Chemoradiotherapy for Localized Esophageal Cancer. Gastroenterology. 2020 Feb;158(3):494-505.e6. doi: 10.1053/j.gastro.2019.10.039. Epub 2019 Nov 9.

  PMID: 31711920 BACKGROUND

• Xu JZ, Wen F, Wang XR. The eIF3a Arg803Lys genetic polymorphism is associated with susceptibility to and chemoradiotherapy efficacy in cervical carcinoma. Kaohsiung J Med Sci. 2017 Apr;33(4):187-194. doi: 10.1016/j.kjms.2017.01.008. Epub 2017 Mar 13.

  PMID: 28359406 BACKGROUND

• Beharee N, Shi Z, Wu D, Wang J. Diagnosis and treatment of cervical cancer in pregnant women. Cancer Med. 2019 Sep;8(12):5425-5430. doi: 10.1002/cam4.2435. Epub 2019 Aug 6.

  PMID: 31385452 BACKGROUND

• Lagheden C, Eklund C, Lamin H, Kleppe SN, Lei J, Elfstrom KM, Sundstrom K, Andrae B, Sparen P, Dillner J. Nationwide comprehensive human papillomavirus (HPV) genotyping of invasive cervical cancer. Br J Cancer. 2018 May;118(10):1377-1381. doi: 10.1038/s41416-018-0053-6. Epub 2018 Mar 21.

  PMID: 29559733 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A total of 80 patients who meet the inclusion criteria and voluntarily sign informed consent forms are planned to be enrolled. According to the acceptable curative treatment measures of the patients, they are divided into two groups: the "operable treatment group (N=40)" and the "curative radiotherapy and chemotherapy treatment group (N=40)". Obtain tumor tissue samples from each enrolled patient (fresh tumor tissue samples (60 mg) or FFPE samples (10-15 pieces) Collect peripheral blood samples of 20 ml/time from multiple treatment nodes of enrolled patients, a total of 7-8 times per person

MeSH Terms

Conditions

Ovarian Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Study Officials

• Jinhua Zhou

  The First Affiliated Hospital of Soochow University，Director of Gynecology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhua Zhou

CONTACT

+86 13914024750; jsjhzh@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: December 1, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2029
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)