AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Sentinel Node Biopsy in Endometrial Cancer

RecruitingPhase 3Ages 18 Years - anyFemaleQueensland Centre for Gynaecological Cancer
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \& similar to a lymph node dissection, the value to patients, cost effectiveness \& potential harms (e.g. lymphedema) of SNB com

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour); 2. Clinically stage I disease (disease confined to body of uterus); 3. Eastern Cooperative Oncology Group (ECOG) performance status of โ‰ค2; 4. Signed written informed consent; 5. Participant must meet criteria for a laparoscopic or robotic surgical approach as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning) 6. All available clinical evidence (physical examination findings, or medical imaging such as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease 7. Myometrial Invasion on MRI of not more than 50%. (Only if participant is \<45yo, has ONLY Grade 1 EAC and wishes to retain their ovaries). 8. Negative (serum or urine) pregnancy test โ‰ค 30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause. Exclusion Criteria: 1. Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and/or through medical imaging. 2. Enlarged retroperitoneal pelvic and/or aortic lymph nodes (\>1 cm) on medical imaging; 3. Estimated life expectancy of less than 6 months; 4. Patients who have absolute contraindications for adjuvant radiotherapy and/or chemotherapy; 5. Patients who have previously received radiation treatment to the pelvis 6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator); 7. Patient compliance and geographic proximity that do not allow adequate follow-up; 8. Patients with allergy to Indocyanine Green (ICG) 9. Patients who have had previous retroperitoneal surgery 10. Patients who require a retroperitoneal (pelvic +/- para-aortic) lymph node dissection (lymphadenectomy) 11. Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu 12. Uterine perforation during endometrial tissue sampling
๐Ÿ’Š

What it tests

  • TH BSO with SNB Note: If participants (โ‰ค45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
  • TH BSO without retroperitoneal node dissection Note: If participants (โ‰ค45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted
๐Ÿ“

Where

23 sites
Houston Methodist Hospital
Houston, United States
Hospital Britanico
Buenos Aires, Argentina
Hospital Italiano
Buenos Aires, Argentina
Chris O'Brien Lifehouse
Camperdown, Australia
Liverpool Hospital
Liverpool, Australia
The Wesley Hospital
Auchenflower, Australia
Greenslopes Private Hospital
Brisbane, Australia
Buderim Private Hospital
Buderim, Australia

โ€ฆand 15 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy