|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02407535 |
|
Date of registration:
|
12/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion
|
|
Scientific title:
|
Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium |
|
Date of first enrolment:
|
March 2015 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02407535 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
Ido Feferkorn, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Carmel Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Patient's age is 18 or above
2. Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the
staging and treatment of endometrial cancer (endometrioid subtype) and with the
relevant suspected symptoms.
3. Patient able to understand,read and sign informed consent.
4. Patient is not participating in other medical trials at present or in the past 30 days
Exclusion Criteria:
1. Age under 18 years
2. Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma
3. Subjects which their biopsy in the pre operating process will include high risk cell
types:
- Grade 3 endometrioid adenocarcinoma,
- clear cell carcinoma
- papillary serous carcinoma
- carcinosarcoma
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Endometrial Endometroid Carcinoma
|
|
Intervention(s)
|
|
Device: Intraoperative ultrasound
|
|
Primary Outcome(s)
|
|
Tumor invasion
[Time Frame: Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)]
|
|
Secondary ID(s)
|
|
CMC-14-0059-CTIL
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|