NCT06197126

Brief Summary

This study aims to validate the value of tumor involvement features based on MRI in cervical cancer, facilitate the development of a more appropriate model for risk stratification, and help patients with varying risk profiles make appropriate decisions in treatment selection and follow-up plans.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Dec 2028

First Submitted

Initial submission to the registry

December 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

4 years

First QC Date

December 25, 2023

Last Update Submit

December 25, 2023

Conditions

Cervical CancerRadiotherapyPrognostic ModelMRI

Outcome Measures

Primary Outcomes (1)

  • overall survival

    the interval from diagnostic day to death or the last follow-up

    1-36 months

Secondary Outcomes (1)

  • progression-free survival

    1-36 months

Study Arms (1)

cervical cancer patients with radiotherapy

Radiotherapy is the main treatment strategy with an overall dose of over 75Gy.

Radiation: Treatment mainly composed of external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT) .

Interventions

Treatment mainly composed of external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT) .RADIATION

The chemotherapy regimens included cisplatin (40 mg/m2) or nedaplatin (80 mg/m2) monotherapy or combined with paclitaxel (135 mg/m2) every three weeks during radiotherapy.

Also known as: concurrent chemothearpy
cervical cancer patients with radiotherapy

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cervical cancer patients received definitive radiotherapy with pre-treatment MRI.

You may qualify if:

  • (1) pathologically confirmed CC, (2) initially treated in our center

You may not qualify if:

  • (1) lack of pre-treatment MRI, (2) prior anti-tumor treatment, (3) pelvic surgery history, (4) incomplete therapy, (5) loss of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Related Publications (10)

  • 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: 33538338BACKGROUND

  • Cibula D, Potter R, Planchamp F, Avall-Lundqvist E, Fischerova D, Haie Meder C, Kohler C, Landoni F, Lax S, Lindegaard JC, Mahantshetty U, Mathevet P, McCluggage WG, McCormack M, Naik R, Nout R, Pignata S, Ponce J, Querleu D, Raspagliesi F, Rodolakis A, Tamussino K, Wimberger P, Raspollini MR. The European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology guidelines for the management of patients with cervical cancer. Radiother Oncol. 2018 Jun;127(3):404-416. doi: 10.1016/j.radonc.2018.03.003. Epub 2018 May 1.

    PMID: 29728273BACKGROUND

  • Matsuo K, Shimada M, Nakamura K, Takei Y, Ushijima K, Sumi T, Ohara T, Yahata H, Mikami M, Sugiyama T. Predictors for pathological parametrial invasion in clinical stage IIB cervical cancer. Eur J Surg Oncol. 2019 Aug;45(8):1417-1424. doi: 10.1016/j.ejso.2019.02.019. Epub 2019 Feb 18.

    PMID: 30846298BACKGROUND

  • Jiang W, He T, Liu S, Zheng Y, Xiang L, Pei X, Wang Z, Yang H. The PIK3CA E542K and E545K mutations promote glycolysis and proliferation via induction of the beta-catenin/SIRT3 signaling pathway in cervical cancer. J Hematol Oncol. 2018 Dec 14;11(1):139. doi: 10.1186/s13045-018-0674-5.

    PMID: 30547809BACKGROUND

  • Lindegaard JC, Petric P, Lindegaard AM, Tanderup K, Fokdal LU. Evaluation of a New Prognostic Tumor Score in Locally Advanced Cervical Cancer Integrating Clinical Examination and Magnetic Resonance Imaging. Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):754-763. doi: 10.1016/j.ijrobp.2019.11.031. Epub 2019 Nov 30.

    PMID: 31794837BACKGROUND

  • Balcacer P, Shergill A, Litkouhi B. MRI of cervical cancer with a surgical perspective: staging, prognostic implications and pitfalls. Abdom Radiol (NY). 2019 Jul;44(7):2557-2571. doi: 10.1007/s00261-019-01984-7.

    PMID: 30903231BACKGROUND

  • Salib MY, Russell JHB, Stewart VR, Sudderuddin SA, Barwick TD, Rockall AG, Bharwani N. 2018 FIGO Staging Classification for Cervical Cancer: Added Benefits of Imaging. Radiographics. 2020 Oct;40(6):1807-1822. doi: 10.1148/rg.2020200013. Epub 2020 Sep 18.

    PMID: 32946322BACKGROUND

  • Tsuruoka S, Kataoka M, Hamamoto Y, Tokumasu A, Uwatsu K, Kanzaki H, Takata N, Ishikawa H, Ouchi A, Mochizuki T. Tumor growth patterns on magnetic resonance imaging and treatment outcomes in patients with locally advanced cervical cancer treated with definitive radiotherapy. Int J Clin Oncol. 2019 Sep;24(9):1119-1128. doi: 10.1007/s10147-019-01457-3. Epub 2019 May 11.

    PMID: 31079257BACKGROUND

  • Bhatla N, Singhal S, Dhamija E, Mathur S, Natarajan J, Maheshwari A. Implications of the revised cervical cancer FIGO staging system. Indian J Med Res. 2021 Aug;154(2):273-283. doi: 10.4103/ijmr.IJMR_4225_20.

    PMID: 35295012BACKGROUND

  • Ren J, Li Y, Yang JJ, Zhao J, Xiang Y, Xia C, Cao Y, Chen B, Guan H, Qi YF, Tang W, Chen K, He YL, Jin ZY, Xue HD. MRI-based radiomics analysis improves preoperative diagnostic performance for the depth of stromal invasion in patients with early stage cervical cancer. Insights Imaging. 2022 Jan 29;13(1):17. doi: 10.1186/s13244-022-01156-0.

    PMID: 35092505BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Yang Sun

CONTACT

+8615959028989sunyang@fjzlhospital.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 9, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

January 9, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)