NCT01649089

Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer

Active, enrolled NA Last updated 3 May 2024

What this trial tests

NA trial testing Conization in Cervical Adenocarcinoma in 224 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 June 2013

Primary endpoint
1 December 2024

1 December 2025

Quick facts

Lead sponsor	GOG Foundation
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	224
Start date	5 June 2013
Primary completion	1 December 2024
Estimated completion	1 December 2025
Sites	185 locations across Canada, United States, South Korea

Drugs / interventions tested

• Conization
• Quality-of-Life Assessment
• Questionnaire Administration
• Therapeutic Conventional Surgery
• Therapeutic Lymphadenectomy

Conditions studied

• Cervical Adenocarcinoma — all drugs for Cervical Adenocarcinoma →
• Cervical Adenosquamous Carcinoma — all drugs for Cervical Adenosquamous Carcinoma →
• Cervical Squamous Cell Carcinoma — all drugs for Cervical Squamous Cell Carcinoma →
• Lymphedema — all drugs for Lymphedema →

Sponsor

GOG Foundation

Who can join

18 and older, female only, with Cervical Adenocarcinoma or Cervical Adenosquamous Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects of surgery.

Publications & conference data

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

1. ConCerv: a prospective trial of conservative surgery for low-risk early-stage cervical cancer.
   Schmeler KM, Pareja R, Lopez Blanco A, Humberto Fregnani J, et al · · 2021 · cited 165× · PMID 34493587 · DOI 10.1136/ijgc-2021-002921
2. Management and Care of Women With Invasive Cervical Cancer: American Society of Clinical Oncology Resource-Stratified Clinical Practice Guideline.
   Chuang LT, Temin S, Camacho R, Dueñas-Gonzalez A, et al · · 2016 · cited 134× · PMID 28717717 · DOI 10.1200/jgo.2016.003954
3. Diagnosis and Management of Adenocarcinoma in Situ: A Society of Gynecologic Oncology Evidence-Based Review and Recommendations.
   Teoh D, Musa F, Salani R, Huh W, et al · · 2020 · cited 60× · PMID 32168211 · DOI 10.1097/aog.0000000000003761
4. Management of Early-Stage Cervical Cancer: A Literature Review.
   Guimarães YM, Godoy LR, Longatto-Filho A, Reis RD. · · 2022 · cited 58× · PMID 35158843 · DOI 10.3390/cancers14030575
5. Fertility-sparing management in cervical cancer: balancing oncologic outcomes with reproductive success.
   Willows K, Lennox G, Covens A. · · 2016 · cited 48× · PMID 27795832 · DOI 10.1186/s40661-016-0030-9
6. Surgery for cervical cancer: consensus & controversies.
   Poddar P, Maheshwari A. · · 2021 · cited 40× · PMID 34854431 · DOI 10.4103/ijmr.ijmr_4240_20
7. Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study.
   Salvo G, Ramirez PT, Leitao MM, Cibula D, et al · · 2022 · cited 34× · PMID 34461074 · DOI 10.1016/j.ajog.2021.08.029
8. Ovarian Conservation and Overall Survival in Young Women With Early-Stage Cervical Cancer.
   Matsuo K, Machida H, Shoupe D, Melamed A, et al · · 2017 · cited 29× · PMID 27926642 · DOI 10.1097/aog.0000000000001754