Clinical Study on the Evaluation of the Efficacy of Cervical Cancer

NCT06254729NOT_YET_RECRUITINGOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Enrollment

4000

Start Date

2024-02-16

Completion Date

2029-02-16

Study Type

OBSERVATIONAL

Official Title

Study on the Application of Multi-omics in the Assessment of Efficacy and Prediction of Side Effects in Cervical Cancer

Interventions

Observational study

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Pathology: patients with pathologically confirmed cervical cancer
* Location: primary tumor of the cervix

Exclusion Criteria:

* Patients with no prior radiation therapy
* Patients without treatment
* Patients without regular follow-up

Outcome Measures

Primary Outcomes

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.

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.

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.

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.

Concentration of Squamous Epithelial Cell Carcinoma Antigen (SCC-Ag)

Concentration of Squamous Epithelial Cell Carcinoma Antigen (SCC-Ag), 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.

Concentration of carbohydrate antigen 125(CA125)

Concentration of carbohydrate antigen 125(CA125), 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.

Count of Bacteria in urine

Count of Bacteria in urine, colony-forming units (CFU)/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.

Count of bacteria in stool

Count of bacteria in stool, colony-forming units (CFU)/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.

5-year overall survival rate of Participants

the proportion of patients who are alive at least 5 years after their initial diagnosis of cancer, regardless of the cause of death,%

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.

disease-free survival of Participants

the length of time from the start of treatment until either the recurrence of cancer or death from any cause, months

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.

progression-free survival of Participants

the start of treatment until either the recurrence of cancer or death from any cause, months

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.

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Clinical Study on the Evaluation of the Efficacy of Cervical Cancer