Clinical Study on the Evaluation of the Efficacy of Cervical Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

The main objectives of this study are to construct a multi-omics-based prognostic and side-effect prediction model for cervical cancer based on pre-treatment imaging, digital pathology, genomics, proteomics, molecular biology, metabolomics, and intestinal flora characteristics data of cervical cancer patients, combined with patients' clinical information, to guide the precise treatment of cervical cancer patients; and to deeply excavate the characteristics related to recurrent cervical cancer based on time-series multi-omics data. Construct an artificial intelligence auxiliary model for dynamic monitoring of cervical cancer recurrence based on longitudinal multi-omics. To provide a real-time and timely tool for clinical early prediction, early identification, early diagnosis and early intervention of cervical cancer, to prolong the survival time and improve the quality of patients' survival.

1. To realize multi-omics feature extraction of cervical cancer patients before treatment, and build a prognosis and side-effect prediction model of cervical cancer to guide accurate treatment; 2. To make iterative, comprehensive, real-time assessment of the risk of recurrence of cervical cancer based on time-series multi-omics data, and to build an early warning model for early identification and early diagnosis of recurrent cervical cancer; 3. To establish a prognostic and side-effect prediction and risk dynamic assessment model for cervical cancer, to build an intelligent decision support system, to implement the application of prognostic and side-effect prediction and dynamic monitoring model, to further assist in the precise diagnosis and treatment of cervical cancer, and to provide an accurate prognostic tool for identifying, diagnosing, and intervening in cervical cancer during the follow-up process.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pathology: patients with pathologically confirmed cervical cancer

Location: primary tumor of the cervix

Disqualifiers

Patients with no prior radiation therapy

Patients without treatment

Patients without regular follow-up

Trial population

Cervical cancer patients receiving radiotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational study

    Other intervention

    Our study does not have any exposure factors.

Treatment groups

4,000 Participants
are divided into 2 treatment groups
Group A: training group1 intervention
Group B: validation group1 intervention

Trial outcomes

Primary outcomes

1

Number of Circulating Tumor Cell Count

Number of Circulating Tumor Cell Count (CTC count), cells/mL

Time frame
From data of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
2

Concentration of Alpha-fetoprotein (AFP)

Concentration of Alpha-fetoprotein (AFP), ng/mL

Time frame
From data of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
3

Concentration of Carcinoembryonic Antigen (CEA)

Concentration of Carcinoembryonic Antigen (CEA), ng/mL

Time frame
From data of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
4

Concentration of carbohydrate antigen 199 (CA199)

Concentration of carbohydrate antigen 199 (CA199), U/mL

Time frame
From data of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital Xi'an Jiaotong University

Lead sponsor

Gansu Maternal and Child Health Hospital

Collaborator

Hanzhong Central Hospital

Collaborator

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