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Procedure

SLN biopsy only for Cervical Cancer (SENTICOLIII Trial)

N/A

Recruiting

Led By Fabrice Lecuru, MD PhD

Research Sponsored by Centre Hospitalier Universitaire de Besancon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

I 1. Patient must be ≥ 18 years old, I 2. With squamous or adenocarcinoma or adenosquamous carcinoma of the cervix (proven by biopsy or cone biopsy), I 3. Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), I 4. Maximum diameter ≤ 40 mm by clinical examination and/or magnetic resonance imaging (MRI), I 5. No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), I 6. ECOG performance status 0-2 (see appendix 2), I 7. Signed informed consent and ability to comply with follow-up, I 8. French subjects: in France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.

Patient must be ≥ 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 3

Awards & highlights

SENTICOLIII Trial Summary

"This trial is a large international study that aims to confirm the effectiveness of using the Sentinel Lymph Node mapping technique in early cervical cancer. They will compare patients who only have the SLN procedure with patients

Who is the study for?

This trial is for adults over 18 with early-stage cervical cancer (specific types like squamous, adenocarcinoma, or adenosquamous carcinoma). The tumor must be smaller than 40mm and not have spread to lymph nodes as seen on MRI. Participants need to be in good enough health to undergo surgery and agree to follow-up visits.Check my eligibility

What is being tested?

The SENTICOL III study is testing if removing only the sentinel lymph node (SLN) in early cervical cancer patients is as effective as removing SLN plus additional pelvic lymph nodes. It's a large international study ensuring surgeons and pathologists follow strict guidelines for quality.See study design

What are the potential side effects?

While specific side effects are not listed, surgical procedures like SLN biopsy can cause pain, swelling, infection risk at the incision site, possible damage to nearby organs or tissues, and complications from anesthesia.

SENTICOLIII Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cervical cancer diagnosis was confirmed by a biopsy.

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My cancer is at an early to mid-stage according to the 2018 FIGO classification.

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My tumor is 40 mm or smaller according to a physical exam or MRI.

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My pelvic MRI showed no suspicious nodes up to my left kidney.

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I can take care of myself and perform daily activities.

SENTICOLIII Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Free Survival (DFS)

Health-related quality of life (HR-QoL)

SENTICOLIII Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SLN biopsy onlyExperimental Treatment1 Intervention

Sentinel lymph node (SLN) biopsy only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.

Group II: SLN biopsy + PLN dissectionActive Control1 Intervention

SLN biopsy + full pelvic lymph node dissection (PLN) will be performed. The radical hysterectomy or trachelectomy will be done.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre Hospitalier Universitaire de BesanconLead Sponsor

444 Previous Clinical Trials

822,520 Total Patients Enrolled

ARCAGY/ GINECO GROUPOTHER

59 Previous Clinical Trials

13,945 Total Patients Enrolled

European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER

36 Previous Clinical Trials

16,251 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this research study?

"As per the details on clinicaltrials.gov, this research is presently seeking suitable candidates. The trial was first listed on 5th March 2018 and most recently revised on 2nd May 2024."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Yes, data available on clinicaltrials.gov indicates that this investigation is actively seeking participants. It was initially listed on the database on May 3rd, 2018 and underwent its latest update on February 5th, 2024. The research aims to recruit a total of 988 individuals from a network of 103 sites."

Answered by AI

How widespread is the participation of medical facilities in Canada for this trial?

"The current enrollment for this research study stands at 103 participants, with recruitment taking place in notable medical centers such as Institut Paoli Calmettes in Marseille, CHU d'Amiens in Amiens, and CHU de Caen in Clamart, along with an additional 100 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

2018. "International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03386734.

All > Cervical Cancer