← Back to Search

Hysterectomy Techniques for Cervical Cancer (SHAPE Trial)

N/A

Waitlist Available

Research Sponsored by Canadian Cancer Trials Group

Eligibility Criteria Checklist

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

Must have

Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix diagnosed by LEEP, cone, or cervical biopsy and reviewed by local gynecological pathologist

Patients who have undergone physical examination, recto-vaginal examination, and visualization of the cervix by speculum or colposcopic examination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

SHAPE Trial Summary

This trial is testing whether a hysterectomy is as effective as a radical hysterectomy in preventing the return of cervical cancer, with the hope that it will have fewer side-effects.

Who is the study for?

Women over 18 with low-risk early-stage cervical cancer confirmed by biopsy, who are not pregnant, have no plans for radiation/chemotherapy post-surgery, and do not wish to preserve fertility. They must be fit for surgery without a history of other malignancies (except certain treated cancers) or evidence of lymph node metastasis.Check my eligibility

What is being tested?

The study is comparing the effectiveness of two surgical procedures: radical hysterectomy versus simple hysterectomy combined with pelvic lymph node dissection in preventing the return of cervical cancer. It also examines if the simpler surgery results in fewer side effects.See study design

What are the potential side effects?

Potential side effects may include pain, bleeding, infection at the surgery site, urinary problems, bowel issues and sexual dysfunction. Long-term risks could involve impacts on bladder and bowel function as well as changes related to sexual health.

SHAPE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cervical cancer diagnosis was confirmed through a biopsy.

Select...

I have had a full pelvic exam, including a visual check of my cervix.

Select...

I am 18 years old or older.

Select...

I am okay with surgery that may affect my ability to have children.

Select...

My cervical cancer is early-stage and considered low-risk.

SHAPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pelvic recurrence rate at 3 years

Secondary outcome measures

Efficacy comparison between treatment arms

SHAPE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Simple HysterectomyExperimental Treatment1 Intervention

Group II: Radical HysterectomyActive Control1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom GermanyUNKNOWN

Institute of Cancer Research, United KingdomOTHER

157 Previous Clinical Trials

129,611 Total Patients Enrolled

Canadian Cancer Trials GroupLead Sponsor

124 Previous Clinical Trials

66,753 Total Patients Enrolled

Media Library

Radical Hysterectomy + pelvic lymph node dissection Clinical Trial Eligibility Overview. Trial Name: NCT01658930 — N/A

Cervical Cancer Research Study Groups: Radical Hysterectomy, Simple Hysterectomy

Cervical Cancer Clinical Trial 2023: Radical Hysterectomy + pelvic lymph node dissection Highlights & Side Effects. Trial Name: NCT01658930 — N/A

Radical Hysterectomy + pelvic lymph node dissection 2023 Treatment Timeline for Medical Study. Trial Name: NCT01658930 — N/A

Frequently Asked Questions

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

Is there still availability for participants to join the clinical trial?

"The information found on clinicaltrials.gov reveals that this specific trial is not presently recruiting patients, having been last updated in July of 2022. However, 398 alternative studies are actively enrolling participants at the present time."

Answered by AI

How many research facilities are actively conducting this trial?

"Potential participants in this medical trial can find it at 17 different sites, including The Jewish General Hospital in Montreal, NCT01658930 in Greenfield Park, and Clinical Research Unit at Vancouver Coastal Health located in Quebec City."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer

2012. "Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01658930.

All > Womens Health > Cervical Cancer