NCT07318701

Brief Summary

The aim of this study is to develop an AI-assisted decision-making system based on multi-agent large language models and to evaluate its effectiveness and accuracy in the diagnosis and treatment of cervical cancer during pregnancy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jan 2026

Shorter than P25 for not_applicable

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 Progress42%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

December 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 18, 2025

Last Update Submit

January 4, 2026

Conditions

Keywords

Large Language ModelCervical cancer during pregnancyMulti-agent

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the MDT decision

    scores, from 0 to 100, accuracy of the MDT decision according to evaluation indicators of each discipline

    immediately after the intervention

Secondary Outcomes (1)

  • Consuming time

    immediately after the intervention

Study Arms (2)

Arm1: multi-disciplinary agents group

EXPERIMENTAL

generate diagnosis and treatment opinions from multi-disciplinary agents

Other: multi-disciplinary agents group

Arm2: real MDT group/ junior doctors group/junior doctors after referring to agent results group

PLACEBO COMPARATOR

generate diagnosis and treatment opinions from real MDT group/ junior doctors group/junior doctors after referring to agent results group

Other: real MDT groupOther: junor doctor groupOther: junor doctor group with aid of MDT agents

Interventions

generate diagnosis and treatment opinions for each case from a real MDT team inclduing senior physicians from relevant departments, including gynecologic oncology, pediatrics, obstetrics, medical oncology and radiation oncology.

Arm2: real MDT group/ junior doctors group/junior doctors after referring to agent results group

generate diagnosis and treatment opinions for each case from junior doctor who are residents from relevant departments, including gynecologic oncology, pediatrics, obstetrics, medical oncology and radiation oncology.

Arm2: real MDT group/ junior doctors group/junior doctors after referring to agent results group

generate diagnosis and treatment opinions for each case from junior doctor who are residents from relevant departments, including gynecologic oncology, pediatrics, obstetrics, medical oncology and radiation oncology after referring to the results from MDT agent .

Arm2: real MDT group/ junior doctors group/junior doctors after referring to agent results group

generate diagnosis and treatment opinions for each case from multi-disciplinary agents

Arm1: multi-disciplinary agents group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed diagnosis of cervical cancer.
  • Confirmed intrauterine pregnancy status via ultrasound.
  • Patients receiving initial treatment.
  • Agreement to participate in the study with signed informed consent.

You may not qualify if:

  • Previous treatment received for cervical cancer during pregnancy.
  • Pathological pregnancy states (e.g., ectopic pregnancy).
  • Inability or unwillingness to provide signed informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Li R, Wang X, Berlowitz D, Mez J, Lin H, Yu H. CARE-AD: a multi-agent large language model framework for Alzheimer's disease prediction using longitudinal clinical notes. NPJ Digit Med. 2025 Aug 24;8(1):541. doi: 10.1038/s41746-025-01940-4.

  • Meyer R, Hamilton KM, Truong MD, Wright KN, Siedhoff MT, Brezinov Y, Levin G. ChatGPT compared with Google Search and healthcare institution as sources of postoperative patient instructions after gynecological surgery. BJOG. 2024 Jul;131(8):1154-1156. doi: 10.1111/1471-0528.17746. Epub 2024 Jan 4. No abstract available.

  • Patel JM, Hermann CE, Growdon WB, Aviki E, Stasenko M. ChatGPT accurately performs genetic counseling for gynecologic cancers. Gynecol Oncol. 2024 Apr;183:115-119. doi: 10.1016/j.ygyno.2024.04.006. Epub 2024 Apr 26.

  • Hermann CE, Patel JM, Boyd L, Growdon WB, Aviki E, Stasenko M. Let's chat about cervical cancer: Assessing the accuracy of ChatGPT responses to cervical cancer questions. Gynecol Oncol. 2023 Dec;179:164-168. doi: 10.1016/j.ygyno.2023.11.008. Epub 2023 Nov 21.

  • Garg P, Mohanty A, Ramisetty S, Kulkarni P, Horne D, Pisick E, Salgia R, Singhal SS. Artificial intelligence and allied subsets in early detection and preclusion of gynecological cancers. Biochim Biophys Acta Rev Cancer. 2023 Nov;1878(6):189026. doi: 10.1016/j.bbcan.2023.189026. Epub 2023 Nov 20.

  • Bedi S, Jain SS, Shah NH. Evaluating the clinical benefits of LLMs. Nat Med. 2024 Sep;30(9):2409-2410. doi: 10.1038/s41591-024-03181-6. No abstract available.

  • Macchia G, Ferrandina G, Patarnello S, Autorino R, Masciocchi C, Pisapia V, Calvani C, Iacomini C, Cesario A, Boldrini L, Gui B, Rufini V, Gambacorta MA, Scambia G, Valentini V. Multidisciplinary Tumor Board Smart Virtual Assistant in Locally Advanced Cervical Cancer: A Proof of Concept. Front Oncol. 2022 Jan 3;11:797454. doi: 10.3389/fonc.2021.797454. eCollection 2021.

  • Amant F, Berveiller P, Boere IA, Cardonick E, Fruscio R, Fumagalli M, Halaska MJ, Hasenburg A, Johansson ALV, Lambertini M, Lok CAR, Maggen C, Morice P, Peccatori F, Poortmans P, Van Calsteren K, Vandenbroucke T, van Gerwen M, van den Heuvel-Eibrink M, Zagouri F, Zapardiel I. Gynecologic cancers in pregnancy: guidelines based on a third international consensus meeting. Ann Oncol. 2019 Oct 1;30(10):1601-1612. doi: 10.1093/annonc/mdz228.

  • Peccatori FA, Azim HA Jr, Orecchia R, Hoekstra HJ, Pavlidis N, Kesic V, Pentheroudakis G; ESMO Guidelines Working Group. Cancer, pregnancy and fertility: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi160-70. doi: 10.1093/annonc/mdt199. Epub 2013 Jun 27. No abstract available.

  • Halaska MJ, Drochytek V, Shmakov RG, Amant F. Fertility sparing treatment in cervical cancer management in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2021 Sep;75:101-112. doi: 10.1016/j.bpobgyn.2021.03.014. Epub 2021 Apr 22.

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

Study Officials

  • Keqin Hua, Doctor

    Gynecology and obstetrics hospital of fudan university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 6, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share