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NCT03778268: SLNMICC

Sentinel Lymph Node Mapping In Cervical Cancer

Status unknown NA Last updated 19 December 2018
What this trial tests

NA trial testing sentinel lymph node biopsy in Uterine Cervical Neoplasms in 1,143 participants. Status unknown.

Timeline
15 December 2018
Primary endpoint
30 June 2020
30 June 2020

Quick facts

Lead sponsorPeking University People's Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment1,143
Start date15 December 2018
Primary completion30 June 2020
Estimated completion30 June 2020
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking University People's Hospital

Who can join

Adults 18 to 80, female only, with Uterine Cervical Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Nanotechnology in cancer diagnosis: progress, challenges and opportunities.
    Zhang Y, Li M, Gao X, Chen Y, et al · · 2019 · cited 227× · PMID 31847897 · DOI 10.1186/s13045-019-0833-3
  2. Image-guided tumor surgery: The emerging role of nanotechnology.
    Wojtynek NE, Mohs AM. · · 2020 · cited 34× · PMID 32162485 · DOI 10.1002/wnan.1624

Verify or expand the search:

Other trials of sentinel lymph node biopsy

Trials testing the same drug.

Other recruiting trials for Uterine Cervical Neoplasms

Currently open trials in the same condition.

Other Peking University People's Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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