Clinical Study on the Evaluation of the Efficacy of Cervical Cancer

NCT06254729 | Not Yet Recruiting

• 1 other identifier: YXJLRH2022039
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 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.

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (11)

• Number of Circulating Tumor Cell Count

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

  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

  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

  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

  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

  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.

  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.

  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

  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,%

  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

  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

  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.

Study Arms (2)

training group

The training group is used to train the model.

Other: Observational study

validation group

The validation group is used to evaluate model performance.

Other: Observational study

Interventions

Observational study OTHER

Our study does not have any exposure factors.

training group; validation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cervical cancer patients receiving radiotherapy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Gansu Maternal and Child Health Hospital: collaborator
• Hanzhong Central Hospital: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, feces, intestinal flora

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Jinlu Ma

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

Central Study Contacts

Jinlu Ma, Doctor

CONTACT

18992842959; majinlu@xjtufh.edu.cn

Mengjiao Cai, Doctor

CONTACT

15339267236; 664642357@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 12, 2024
• Study Start: February 16, 2024
• Primary Completion (Estimated): February 16, 2029
• Study Completion (Estimated): February 16, 2030
• Last Updated: February 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share