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Sentinel Lymph Node Mapping In Cervical Cancer

NCT03778268UNKNOWNNAINTERVENTIONAL

Summary

Lymph node assessment provides the crucial information about the prognosis of cervical cancer. Sentinel lymph node stands in the first station on the lymph node metastasis pathways. While traditional systemically lymph node resection would bring a lot of complications, sentinel node mapping and biopsy is a feasible way with less damage to evaluate whether lymph node metastasis occurs in early cervical cancer patients, due to less lymph nodes resected. However, the process of this technology isn't well established. The investigators intend to conduct a prospective and multicentric study to evaluate the effectiveness of different mapping methods to achieve a reliable lymph node assessment. Early cervical cancer patients in each center will be recruited in the investigators' study with inclusion and exclusion criteria. After the patients signing the informed consent form, the surgery process will be performed, including sentinel lymph node mapping with Carbon Nanoparticles (CNP) or CNP combining Indocyanine Green(ICG), extra-fascial/sub-extensive/extensive hysterectomy, pelvic with or without para-aortic lymph node resection, sequentially. All resected nodes will be pathologically exanimated. Then the data obtained will be analyzed and discussed deeply and finally lead to a conclusion.

Key Facts

Lead Sponsor

Peking University People's Hospital

Enrollment

1143

Start Date

2018-12-15

Completion Date

2020-06-30

Study Type

INTERVENTIONAL

Official Title

Comparing the Diagnostic Value of Different Lymph Node Tracing Methods in Detecting Sentinel Lymph Node Metastasis in Early Cervical Cancer

Interventions

sentinel lymph node biopsy

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

Inclusion Criteria:

* Diagnosis of early cervical cancer (FIGO IA1 with LVSI (+) to IIA).
* Decide to receive extra-fascial/sub-extensive/extensive hysterectomy, pelvic with or without aortic lymph node resection
* Agree to conduct the study and sign an informed consent form

Exclusion Criteria:

* Diagnosis of cervical cancer in FIGO IIB stage and above
* History of previous pelvic or inguinal lymphadenectomy or other history of surgery affecting the uterine lymphatic drainage
* Other history of pelvic or abdominal malignant tumors in the past 5 years
* Intolerable for surgery due to severe comorbidities
* During a period of pregnancy
* Allergic to the tracer
* Diagnosis of uncontrolled epilepsy, central nervous system disease or mental disorder, with the judgment from the investigator that the above diseases would affect clinical research compliance.

Outcome Measures

Primary Outcomes

Negative Predictive Value

Sentinel lymph node detection is defined as at least one lymph node is found in a patient. Sentinel lymph node negative is defined as no sentinel lymph node detected. True negative is defined as no metastasis found in both sentinel lymph nodes (SLNs) and non-SLNs. Negative predictive value is defined as the proportion of true negative patients to SLNs negative patients in patients with sentinel lymph nodes detected, which means patients without SLNs detected won't be included in the calculation.

Time frame: Through study completion, an average of 2 years

Secondary Outcomes

SLNs detection rate

Sentinel lymph node detection is defined as at least one lymph node is found in a patient. The detection rate is the proportion of the patients with SLNs detected in all enrolled patients.

Time frame: Through study completion, an average of 2 years

Sensitivity

Sensitivity is defined as the proportion of the SLNs positive patients in patients with SLNs or non-SLNs lymphatic metastasis (among the patients with SLNs detected)

Time frame: Through study completion, an average of 2 years

False negative rate

False negative is defined as no metastasis found in SLNs while metastasis found in non-SLNs. False negative rate is defined as the proportion of the false negative patients in the patients with SLNs or non-SLNs lymphatic metastasis(among the patients with SLNs detected)

Time frame: Through study completion, an average of 2 years

Locations

Peking University People's Hospital, Beijing, China

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.