MRI-based Signatures for Survival Prediction in Cervical Cancer With Radiotherapy

NCT ID: NCT06197126

Last Updated: 2024-01-09

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Even with the development of advanced technology, the prognosis for CC patients who received radiotherapy is still an intractable problem. Almost 40% suffered disease recurrence among locally advanced patients after radiotherapy and the reported 5-year overall survival is 50-70%. The present FIGO staging is controversial in pre-treatment assessment, which is mainly based on physical examination. An ambiguous diagnosis leads to different treatment strategies and follow-up plans, which is associated with prognosis non-improvement. Incorporation of the tumor involvement features based on the MRI into pre-treatment assessment could standardize and improve the consistency and repeatability of diagnosis.

Conditions

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Cervical Cancer Radiotherapy Prognostic Model MRI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cervical cancer patients with radiotherapy

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

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

Intervention Type 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.

Interventions

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

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.

Intervention Type RADIATION

Other Intervention Names

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concurrent chemothearpy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fujian Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Central Contacts

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Yang Sun

Role: CONTACT

+8615959028989

References

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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.

Reference Type BACKGROUND
PMID: 33538338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29728273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30846298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30547809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31794837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30903231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32946322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31079257 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35295012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35092505 (View on PubMed)

Other Identifiers

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SY-GO001

Identifier Type: -

Identifier Source: org_study_id

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