Peritoneal CarcinomatosisNCT03798132
Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic.
An observational study of Peritoneal Carcinomatosis, run by Shimaa Abdalla Ahmed at 1 site in Egypt.
Trial summary
pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- laparoscopy
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to Dec 2020
- 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 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pathologically proved ovarian cancer patients recived cytoreductive surgery and underwent preoperative CT and diagnostic laparoscopy
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute
Asyut, 11517
Shimaa Ahmed, Lecturer, 01007653325, shimaaabdalla@aun.edu.eg
About this study
Official title: Imaging Evaluation of Peritoneal Carcinomatosis Extent
pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.
Read the detailed description
we will search medical records of primary ovarian cancer patients underwent CT abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality.
Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of peritoneal carcinomatosis was classified into 3 categories low if PCI < 10, moderate if 10-20, and large if >20.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- laparoscopy
- Keywords
- Ovarian Neoplasms, Laparoscopy, Cytoreduction Surgical Procedures.
- Medical subject headings
- Peritoneal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopyDiagnostic test
evaluation of peritoneal carcinomatosis by laparoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
peritoneal carcinomatosis
Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement.
Measured: one year
Secondary outcomes (1)
surgical decision making.
correlation of peritoneal carcinomatosis categorization with surgical decision
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Jan 2019
- Primary completion11 Jun 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shimaa Abdalla Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shimaa Abdalla Ahmed, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798132
- Sponsor's protocol ID
- SouthECI
- Status last verified
- Jan 2019
- First submitted
- 7 Jan 2019
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.
PubMed 18801470
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Evaluation of Peritoneal Carcinomatosis Extent
- ClinicalTrials.gov ID
- NCT03798132
- Acronym / sponsor ID
- SouthECI
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- Ovarian Neoplasms, Laparoscopy, Cytoreduction Surgical Procedures.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shimaa Abdalla AhmedUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 11 Jun 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Jan 2019 (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.
pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.
Detailed description
we will search medical records of primary ovarian cancer patients underwent CT abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality.
Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of peritoneal carcinomatosis was classified into 3 categories low if PCI < 10, moderate if 10-20, and large if >20.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pathologically proved ovarian cancer patients recived cytoreductive surgery and underwent preoperative CT and diagnostic laparoscopy
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| laparoscopyevaluation of peritoneal carcinomatosis by laparoscopy | Diagnostic test | – |
Primary outcome
peritoneal carcinomatosis
Time frame: one year
Agreement in general and in each category between CT, laparoscopy, surgery and pathology was assessed using kappa agreement.
1 secondary outcome
surgical decision making.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Background: PubMed 18801470Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17.
- Individual participant dataSharing planned: Undecided
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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.
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 Peritoneal Carcinomatosis, run by Shimaa Abdalla Ahmed 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 0 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 9 Jan 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peritoneal carcinomatosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798132, which also lists 1 linked publication.
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 9 Jan 2019.