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

Recruiting now

Conditions studied: Ovarian Cancer, Epithelial

In brief

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.

Key facts

Study ID

NCT06640348

Run by

Anhui Provincial Hospital

People needed

70

Starts

2025-01-01

Expected to finish

2030-12-31

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• Anhui Provincal Hospital — Hefei, Anhui, China (enrolling)

Full record on ClinicalTrials.gov

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