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AzTrials

Cervical CancerNCT07318701

Multi-agent LLMs for Decision Support in Cervical Cancer During Pregnancy

A study testing multi-disciplinary agents group, real MDT group and junor doctor group in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Cervical Cancer
What is being tested?
multi-disciplinary agents group, real MDT group and junor doctor group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Multi-agent Large Language Models for Multidisciplinary Decision Support in Cervical Cancer During Pregnancy

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.

Read the detailed description

This project intends to construct China's first artificial intelligence model for the vertical field of "multidisciplinary team (MDT) consultation" for cervical cancer during pregnancy. Centered on the massive case data of gynecological oncology from Obstetrics and Gynecology Hospital of Fudan University, combined with cervical cancer during pregnancy guidelines to formulate multi-oncology department judgment standards, it will focus on overcoming key technical bottlenecks such as model reliability, model result evaluation, and multi-agent collaborative scheduling. With this model as the engine, a trinity AI hub will be built, driven by agent collaboration and combined with a guideline-based evaluation system to realize intelligent support for " cervical cancer during pregnancy MDT consultation + guideline evaluation". By constructing a vertical model for MDT consultation for cervical cancer during pregnancy, MDT AI agent consultation, and a guideline-based evaluation system, the project will comprehensively improve the standardization, homogenization level and efficiency of diagnosis and treatment, promote the upgrading of the diagnosis and treatment capabilities for cervical cancer during pregnancy diagnosis and treatment capabilities, and provide more accurate and high-quality medical service guarantees for patients.

  1. Vertical Large Language Model Based on the guidelines for cervical cancer during pregnancy and other relevant authoritative guidelines and expert consensus, it provides high-quality structured knowledge support and reliable decision-making explanation basis for the gynecological oncology vertical model. Construct a high-quality gynecological oncology vertical corpus: Address the difficulty of manual corpus construction, build controllable data generation based on the existing full tumor process, establish a gynecological oncology corpus with high accuracy and strong generalization ability, and enhance the quality of fine-tuning data. Construct a vertical gynecological oncology large language model: Improve the basic professional capabilities of the model through methods such as maximizing internal coherence and measuring mutual predictability; introduce a length penalty mechanism and neighborhood-adaptive reinforcement learning based on large language models to enable the language model to discriminate gynecological oncology logic. Through a reference reward mechanism based on standard answers, the gynecological guideline reward model supports the reinforcement learning of the gynecological model and solves the key problem of model interpretability. Improve core clinical tasks such as early screening, accurate staging diagnosis, personalized treatment plan recommendation, risk stratification assessment and intelligent follow-up of gynecological tumors, achieve or exceed the level of international advanced similar models in key performance indicators, and provide scientific and reliable intelligent support for clinical diagnosis and treatment decisions.
  2. Agent Construction Construct a collaborative intelligent platform driven by exclusive diagnosis and treatment agents for each department: With hierarchical modular design as the core and agent cluster as the driving force, it covers the full-cycle diagnosis and treatment process of cervical cancer during pregnancy. The underlying data layer integrates clinical business data and specialized knowledge bases to support the diverse AI capabilities of the model layer; the Agent framework layer, as the technical hub, realizes multi-model scheduling, long-term and short-term memory management, and automatic arrangement of diagnosis and treatment processes through modules such as model gateway, memory enhancement, and strategy orchestration; the platform management layer provides visual scenario configuration, rule engine and workflow management to ensure medical compliance; the application layer includes gynecological oncology, neonatology, chemotherapy, and obstetrics agents to form a collaborative network. Design task routing and time-sharing classification scheduling strategies, assign tasks based on Agent capabilities and load, prioritize quality control and auxiliary diagnosis and treatment tasks, and improve computing power efficiency; realize the full life cycle management of Agents, including registration, release, and optimization, configure vertical model binding, prompts, etc., optimize corpus quality through user feedback, and coordinate the division of labor among multiple Agents through workflow engine to solve problems such as dynamic branches of complex diagnosis and treatment paths and knowledge tool collaboration, ensuring efficient collaboration. Construct the platform's intelligent scheduling and management capabilities for Agents: Design task routing to assign tasks based on Agent capabilities and current load; statistically analyze Agent usage efficiency and frequency to design execution priorities, and improve the efficiency of computing resource utilization. Design time-sharing classification scheduling strategies based on the confidence interval of AI in clinical business and the feasibility priority of non-core process substitution. Provide independent deployment capabilities for core businesses to avoid computing resource contention, ensure scheduling executability, and improve business resilience.
  3. Guideline-Based MDT Decision Evaluation System Analyze and restructure knowledge based on the Guidelines for cervical cancer during pregnancy, extract key diagnosis and treatment points applicable to MDT, and establish an exclusive evaluation index system covering gynecological oncology, obstetrics, chemotherapy, and neonatology to quantitatively evaluate and compare diagnosis and treatment plans from different sources.

In real case datasets, we will retrospectively enrolled patients diagnosed as cervical cancer during in obstetrics and gynecology hospital from January 2007 to December 2025. The inclusion criteria is as follows: 1) Pathologically confirmed diagnosis of cervical cancer; 2) Confirmed intrauterine pregnancy status via ultrasound. 3) Patients receiving initial treatment. 4)Agreement to participate in the study with signed informed consent. The exclusion criteria is as follows: 1) Previous treatment received for cervical cancer during pregnancy. 2) Pathological pregnancy states (e.g., ectopic pregnancy). 3) Inability or unwillingness to provide signed informed consent. For each case, we will collect diagnosis and treatment opinions from multi-disciplinary agents, junior doctors, and junior doctors after referring to agent results respectively. Then we calculate and compare accuracy and consistency scores according to evaluation indicators of each discipline for the three parties' results.

In virtual case datasets, similar to criteria for the retrospective study section, 100 virtual cases of cervical cancer during pregnancy were generated. These cases were randomly divided in a 1:1 ratio into MDT-agents group and a real MDT team group. We will calculate accuracy and compare results according to the same evaluation indicators. Besides, we will also compare the consuming time for each case by MDT-agents and real MDT team respectively.

Conditions
Cervical Cancer
Being tested
multi-disciplinary agents group, real MDT group, junor doctor group, junor doctor group with aid of MDT agents
Keywords
Large Language Model, Cervical cancer during pregnancy, Multi-agent
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multi-disciplinary agents groupOther

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

  • real MDT groupOther

    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.

  • junor doctor groupOther

    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.

  • junor doctor group with aid of MDT agentsOther

    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 .

Study groups in NCT07318701
Study groupRoleWhat they receive
Arm1: multi-disciplinary agents groupExperimentalgenerate diagnosis and treatment opinions from multi-disciplinary agents
Receives: Other: multi-disciplinary agents group
Arm2: real MDT group/ junior doctors group/junior doctors after referring to agent results groupPlacebo comparatorgenerate diagnosis and treatment opinions from real MDT group/ junior doctors group/junior doctors after referring to agent results group
Receives: Other: real MDT group; Other: junor doctor group; Other: junor doctor group with aid of MDT agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of the MDT decision

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

    Measured: immediately after the intervention

Secondary outcomes (1)
  1. Consuming time

    seconds, consuming time for generating MDT decisions from MDT agents/ real MDT team

    Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07318701
Sponsor's protocol ID
2025-33
Status last verified
Jan 2026
First submitted
18 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40849361
  • 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.

    PubMed 38177090
  • 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.

    PubMed 38676973
  • 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.

    PubMed 37988948
  • 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.

    PubMed 37980945
  • 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.

    PubMed 39060659
  • 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.

    PubMed 35047408
  • 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.

    PubMed 31435648
  • 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.

    PubMed 23813932
  • 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.

    PubMed 33992541

Questions about this trial

What is this clinical trial studying?

A study testing multi-disciplinary agents group, real MDT group and junor doctor group in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Keqin Hua, Doctor (+86-021-33189900, huakeqinjiaoshou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of the MDT decision (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07318701, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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