Ultrasensitive SERS Platform With Highly Efficient Enrichment of Analyte for Screening and Diagnosis of Epithelial Ovarian Cancer

NCT06640348 | Recruiting

• 1 other identifier: YingZhou 2024-10
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This project is an open, single-center, prospective study aimed at developing high-sensitivity, high-specificity enrichment SERS chips using femtosecond laser processing technology. It involves extracting information from blood samples of ovarian cancer patients and normal controls, specifically identifying cancer and non-cancer signals. The study will construct a statistical algorithm model for the early diagnosis of ovarian cancer, enabling early identification and intervention for ovarian cancer patients.

Conditions

Ovarian Cancer, Epithelial

Outcome Measures

Primary Outcomes (2)

• PFS PFS

  progression free survival

  one year

• OS

  OS (overall survival) is defined as the time which begins at diagnosis and up to the time of death

  three year

Study Arms (2)

healthy control

By analyzing the Raman signals of peripheral serum from normal controls, unique signal characteristics specific to ovarian cancer patients are identified through comparative analysis with the control group.

Other: No intervention

Ovarian cancer group

Extract information from blood samples of ovarian cancer patients, specifically identifying cancer and non-cancer signals to construct a statistical algorithm model for the early diagnosis of ovarian cancer.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Ovarian cancer group; healthy control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects include patients with epithelial ovarian cancer, while the control group consists of patients undergoing surgery for benign diseases.

You may qualify if:

• The subjects understand the trial process, sign the informed consent form, voluntarily participate in the study, and are capable of following the protocol;
• Aged 18 to 70 (inclusive):
• Cancer group: Ovarian cancer patients (50 cases of high-grade serous ovarian cancer, 15 cases of low-grade serous ovarian cancer, 20 cases of endometrioid ovarian cancer, 20 cases of clear cell carcinoma) i. All ovarian cancer patients are initial treatment patients with complete clinical data; ii. Patients have an ECOG performance status score of 0-3 and a life expectancy of more than 6 months; iii. Subjects consent to blood sample collection for SERS analysis (provided free of charge); iv. Good organ function.
• Normal control group: (20 cases) i. Normal control subjects are patients undergoing surgery for benign diseases; ii. Patients have complete clinical data; iii. Subjects have not undergone any radical treatment for the benign lesion prior to blood collection.

You may not qualify if:

• Severe or uncontrolled diseases, including but not limited to: uncontrollable nausea and vomiting, gastrointestinal diseases that may interfere with drug absorption and metabolism, mental illnesses affecting the patient's ability to sign the informed consent form, a history of severe cardiovascular disease, infectious diseases (such as syphilis, AIDS, active hepatitis C, or active hepatitis B), infectious conditions (such as abscesses), or active rheumatic diseases, etc.;
• A history of blood transfusion within 4 weeks prior to the study;
• Pregnant, postpartum, or breastfeeding patients, or patients planning to become pregnant during the study treatment;
• Patients with a history of other tumors;
• The investigator deems the subject unsuitable for participation in this clinical study.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provincal Hospital

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Ying Zhou, MD

CONTACT

_8613865901025; caddiezy@ustc.edu.cn

Ying Zhou, MD

CONTACT

caddiezy@ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)