Adnexal MassNCT03442881
The Use of International Ovarian Tumor Analysis and Assessment of Adnexal Neoplasia in Differentiating Malignant and Benign Adnexal Masses
An observational study of Adnexal Mass, run by Cairo University at 1 site in Egypt.
Trial summary
All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three… Read more about this study
- Who is it for?
- Ages 15 to 70 years, women only
- Conditions the study is for
- Adnexal Mass
- What is being tested?
- Excision of adnexal mass through laprotomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2018to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study included 80 patients who had a preliminary diagnosis of adnexal mass clinically and/or sonographically
Who may be able to join
- Women with clinically and sonographically diagnosed adenxal mass more than 5 cm in diameter. 2. Patients who will undergo surgical intervention . 3. Patients are recruited regardless of age, parity and complaint
Who cannot join
- Patients treated with conservative management. 2. Patients known to be pregnant.
Trial locations and contacts
1 site in 1 country.
Karim Salama, MSc contact
About this study
Official title: The Use of International Ovarian Tumor Analysis and Assessment of Different Neoplasia in the Adnexa Model in Differentiating Malignant and Benign Adnexal Masses
All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen
Read the detailed description
All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen
- Conditions
- Adnexal Mass
- Being tested
- Excision of adnexal mass through laprotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of adnexal mass through laprotomyProcedure or surgery
Through laparotomy incision, the adnexal mass will be excised
| Study group | Role | What they receive |
|---|---|---|
| benign adnexal mass | pathological examination of the specimen after excision reveals benign criteria Receives: Procedure: Excision of adnexal mass through laprotomy | |
| Malignant adnexal mass | pathological examination of the specimen after excision reveals malignant criteria Receives: Procedure: Excision of adnexal mass through laprotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature of the mass
Benign or malignant criteria of the excised adnexal mass
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal MassStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442881
- Sponsor's protocol ID
- 28
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of International Ovarian Tumor Analysis and Assessment of Different Neoplasia in the Adnexa Model in Differentiating Malignant and Benign Adnexal Masses
- ClinicalTrials.gov ID
- NCT03442881
- Acronym / sponsor ID
- 28
- Conditions
- Adnexal Mass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen
Detailed description
All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign adnexal mass | – | Procedure: Excision of adnexal mass through laprotomypathological examination of the specimen after excision reveals benign criteria |
| Malignant adnexal mass | – | Procedure: Excision of adnexal mass through laprotomypathological examination of the specimen after excision reveals malignant criteria |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included 80 patients who had a preliminary diagnosis of adnexal mass clinically and/or sonographically
Key inclusion criteria (1 listed)
- Women with clinically and sonographically diagnosed adenxal mass more than 5 cm in diameter. 2. Patients who will undergo surgical intervention . 3. Patients are recruited regardless of age, parity and complaint
Key exclusion criteria (1 listed)
- Patients treated with conservative management. 2. Patients known to be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excision of adnexal mass through laprotomyThrough laparotomy incision, the adnexal mass will be excised | Procedure or surgery | Malignant adnexal mass, benign adnexal mass |
Primary outcome
Nature of the mass
Time frame: At time of surgery
Benign or malignant criteria of the excised adnexal mass
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Salama, MSc contact
Ahmed Maged, MD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Mass, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (+2001005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature of the mass (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.