Sentinel Lymph Node Mapping In Cervical Cancer

NCT03778268 | Unknown DMC

• 1 other identifier: 2018PHD003-01
• Study Type: interventional
• Target: 1,143
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Uterine Cervical Neoplasms

Keywords

Sentinel Lymph Node Biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 2 years

Secondary Outcomes (3)

• SLNs detection rate

  Through study completion, an average of 2 years

• Sensitivity

  Through study completion, an average of 2 years

• False negative rate

  Through study completion, an average of 2 years

Study Arms (1)

Undergoing sentinel lymph node biopsy

EXPERIMENTAL

This group of patients will undergo sentinel lymph node biopsy.

Procedure: sentinel lymph node biopsy

Interventions

sentinel lymph node biopsy PROCEDURE

1. Injecting carbon nanoparticles (CNP)\[Not Equipped with near-infrared fluorescent vascular imager\] or CNP combining Indocyanine Green(ICG)\[Equipped with near-infrared fluorescent vascular imager\]. 2. Identifying and removing sentinel lymph nodes. 3. Staining all nodes using hematoxylin-eosin staining.

Undergoing sentinel lymph node biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Chinese Academy of Medical Sciences: collaborator
• Peking University International Hospital: collaborator
• Shanghai First Maternity and Infant Hospital: collaborator
• Obstetrics & Gynecology Hospital of Fudan University: collaborator
• Sun Yat-sen University: collaborator
• Tianjin Central Hospital of Gynecology Obstetrics: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator
• First People's Hospital of Foshan: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Second Affiliated Hospital of Zhengzhou University: collaborator
• Beijing Blue Sky Shared Health Management Co., Ltd.: collaborator
• Chongqing Lummy Pharmaceutical Co.,Ltd.: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (6)

• Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

  PMID: 25220842 BACKGROUND

• Creasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41. doi: 10.1002/1097-0142(19901015)60:8+3.0.co;2-8.

  PMID: 3652025 BACKGROUND

• NCCN Guidelines Version 1. 2018. Cervical Cancer [EB/OL]. [2018-02-10]. http://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf.

  BACKGROUND

• Lu Y, Wei JY, Yao DS, Pan ZM, Yao Y. Application of carbon nanoparticles in laparoscopic sentinel lymph node detection in patients with early-stage cervical cancer. PLoS One. 2017 Sep 5;12(9):e0183834. doi: 10.1371/journal.pone.0183834. eCollection 2017.

  PMID: 28873443 BACKGROUND

• Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.

  PMID: 28566221 BACKGROUND

• Liang SC, Wang ZQ, Wang JL. [Clinical analysis of 76 cases of sentinel lymph node detection in cervical cancer and endometrial cancer]. Zhonghua Fu Chan Ke Za Zhi. 2017 Sep 25;52(9):605-611. doi: 10.3760/cma.j.issn.0529-567X.2017.09.006. Chinese.

  PMID: 28954449 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Jianliu Wang, Professor

  Peking University People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Jianliu Wang, Professor

CONTACT

88324385; wangjianliu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The procedure is listed as follows: 1. Recruiting early stage cervical cancer patients undergoing extra-fascial/sub-extensive/extensive hysterectomy, pelvic with or without aortic lymph node resection from July 2018 to June 2020. 2. Selecting the Standard-compliant patients according to the inclusion and exclusion criteria. 3. Numbering the above patients and collecting their clinical data. 4. Injecting carbon nanoparticles (CNP)\[Not Equipped with near-infrared fluorescent vascular imager\] or CNP combining Indocyanine Green(ICG)\[Equipped with near-infrared fluorescent vascular imager\]. 5. Identifying and removing sentinel lymph nodes. 6. Completing the total hysterectomy, biadnexectomy and pelvic with or without para-aortic lymphadenectomy. 7. Staining all nodes using hematoxylin-eosin staining. 8. Calculating the sensitivity, negative predictive value, etc.

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: December 15, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (2)