New method for early detection of epithelial ovarian cancer using blood samples

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

This study is testing a new blood test to see if it can help detect ovarian cancer earlier by looking for specific signals in the blood of patients and healthy people.

Quick facts

• Study type: Observational
• Enrollment: 70 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Anhui Provincial Hospital (other gov)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06640348 on ClinicalTrials.gov

What this trial studies

This observational study focuses on developing a highly sensitive and specific SERS chip for the early diagnosis of epithelial ovarian cancer. By analyzing blood samples from ovarian cancer patients and healthy controls, the study aims to identify distinct cancer signals and construct a statistical model for diagnosis. The research utilizes advanced femtosecond laser processing technology to enhance the detection of key biomolecules, ultimately providing a foundation for improved screening methods. The study will also explore the interaction patterns between SERS active particles and biomolecules to refine the diagnostic process.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 with confirmed cases of epithelial ovarian cancer or individuals undergoing surgery for benign diseases.

Not a fit: Patients with advanced ovarian cancer who have already undergone radical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier and more accurate detection of ovarian cancer, improving patient outcomes.

How similar studies have performed: While there have been advancements in cancer detection technologies, this specific approach using SERS chips for ovarian cancer screening is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. The subjects understand the trial process, sign the informed consent form, voluntarily participate in the study, and are capable of following the protocol;
2. 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.

Exclusion Criteria:

1. 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.;
2. A history of blood transfusion within 4 weeks prior to the study;
3. Pregnant, postpartum, or breastfeeding patients, or patients planning to become pregnant during the study treatment;
4. Patients with a history of other tumors;
5. The investigator deems the subject unsuitable for participation in this clinical study.

Where this trial is running

Hefei, Anhui

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

Study contacts

• Study coordinator: Ying Zhou, MD

Conditions: Ovarian Cancer, Epithelial