INTERNATIONAL VALIDATION STUDY OF SENTINEL NODE BIOPSY IN EARLY CERVICAL CANCER

Phase 3

• Conditions: Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecifiedHealth Condition 2: C00-D49- Neoplasms

• Registration Number: CTRI/2021/04/033080
• Lead Sponsor: Centre Hospitalier Universitaire de Besanon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patient must be � 18 years old.

2. With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy)

3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1, Ib2 and IIa1, (clinical stage) of the 2018 FIGO

classification.

4. Maximum diameter � 40 mm by clinical examination and/or magnetic resonance imaging (MRI)

5. No suspicious on pelvic MRI with an exploration up to the left renal vein

6. ECOG performance status 0-2

7. Signed informed consent and ability to comply with follow-up

Exclusion Criteria

1. Pregnancy,

2. Previous pelvic or abdominal cancer,

3. Previous chemotherapy and/or radiation therapy for cervical cancer

(previous brachytherapy is accepted),

4. Proven allergy to blue dye, isotope or indocyanine green (ICG)

5.Other malignancy within the last 5 years except for treated cancer-free of disease and treatment,

6.Patients with synchronous cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified