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NCT06640348Recruiting

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

Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
11 Oct 2024
Start date
1 Jan 2025
Primary completion date
31 Dec 2027
Lead sponsor
Anhui Provincial Hospital
NCT number
NCT06640348

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 1 Jan 2025 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • A history of blood transfusion within 4 weeks prior to the study;

Other illness

  • 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.;
  • Patients with a history of other tumors;

Other

  • Pregnant, postpartum, or breastfeeding patients, or patients planning to become pregnant during the study treatment;
  • The investigator deems the subject unsuitable for participation in this clinical study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anhui Provincal Hospital
Coordinator of this site? Confirm its status
HefeiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.