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The application and prognostic value of sentinel lymph node biopsy in stage II ovarian cancer

The application and prognostic value of sentinel lymph node biopsy in stage II ovarian cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052255
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-12-31
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Interventions

Sponsors

Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Females aged 18-80 years; 2. FIGO stage II ovarian cancer: Ultrasound and CT showed suspicious adnexal mass (unilateral or bilateral) or surgically confirmed ovarian cancer (unilateral or bilateral salpingo-oophorectomy with or without hysterectomy); 3. Negative lymph nodes on preoperative imaging, defined as the largest diameter of lymph nodes < 1 cm; 4. Proper respiratory, liver, heart, bone marrow, liver and kidney function; 5. Have not received any treatment related to the disease before this study, including surgery, chemotherapy, radiotherapy and other anti-tumor drug treatment; 6. Have complete clinical data, such as imaging data to evaluate tumor size, location, clinical stage, tumor markers CEA, CA19-9, CA125, etc.; 7. Patients voluntarily joined the study and signed the informed consent for clinical specimen sampling; 8. Female patients of childbearing age must have a negative HCG test; and must be non-breastfeeding.

Exclusion criteria

Exclusion criteria: 1. Extra-pelvic spread on initial imaging or surgical exploration and confirmed stage III or IV; 2. Previous vascular surgery of the aorta, inferior vena cava and/or blood vessels; 3. Previous lymph node dissection or lymph node sampling in the pelvic or para-aortic area; 4. The subject has suffered from other malignant tumors such as malignant lymphoma, abdominal malignant tumor, etc. in the past 5 years or at the same time; 5. History of hypersensitivity to colloid, indocyanine green (ICG), iodine, iodine dyes, isoendosulfan blue or triphenylmethane; 6. According to the judgment of the researcher, the subjects have other factors that may lead to the forced termination of the study.

Design outcomes

Primary

MeasureTime frame
Diagnostic sensitivity;Diagnostic specificity;Sentinel lymph node detection rate;

Secondary

MeasureTime frame
Safety;Feasibility;

Countries

China

Contacts

Public ContactYao Liangqing

Obstetrics and Gynecology Hospital of Fudan University

yaoliangqing@163.com+86 21 33189900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026