Ovarian CancerNCT05840029
VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES
An observational study of Ovarian Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
Ovarian cancer is the seventh most common cancer and the fifth leading cause of death in women worldwide. About 70% of patients with epithelial ovarian cancer present with advanced disease which will require a combination of cytoreductive surgery and chemotherapy to give them their best chance of long term… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- VIDEO-ASSISTED THORACOSCOPIC SURGERY
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Apr 2023
- 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 20 to 80 years
- Women only
- Adult, Older adult
Study population: Patients with advanced ovarian cancer at gyneoncology department will be enrolled
Who may be able to join
- FIGO stage III/IV ovarian cancer with or without pleural effusion
Who cannot join
- Previously treated ovarian disease.
- Patient unfit for single lung ventilation.
- Patients with previous lung surgery.
- Patients with possible intrapleural adhesions.
- Patients who had pulmonary resection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE ROLE OF VIDEO-ASSISTED THORACOSCOPIC SURGERY IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES
Ovarian cancer is the seventh most common cancer and the fifth leading cause of death in women worldwide.
About 70% of patients with epithelial ovarian cancer present with advanced disease which will require a combination of cytoreductive surgery and chemotherapy to give them their best chance of long term survival.The presence of macroscopic pleural disease-especially if undetected and unresected after primary debulking surgery-may alter treatment decision-making and markedly affect survival. Video-Assisted Thoracoscopic Surgery (VATS) allows surgeons, through a minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.
Few studies reported that VATS altered the therapeutic management in ovarian cancer patients leading to an upstaging or down-staging when compared to the CT staging. Therefore, this study will prospectively assess the role of VATS in the diagnosis and management of supradiaphragmatic disease as well as evaluate the impact of VATS findings on the decision of surgical management in patients with advanced ovarian cancer FIGO (The International Federation of Gynecology and Obstetrics) stage III/IV.
- Conditions
- Ovarian Cancer
- Being tested
- VIDEO-ASSISTED THORACOSCOPIC SURGERY
- Keywords
- ovarian cancer stage III, IV; VATS, CT staging
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIDEO-ASSISTED THORACOSCOPIC SURGERYProcedure or surgery
Also called VATS
A minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Patients who will get neoadjuvant chemotherapy based on VATS finding. | Patients will be considered to receive neoadjuvant chemotherapy if there is residual intrathoracic disease Receives: Procedure: VIDEO-ASSISTED THORACOSCOPIC SURGERY | |
| Group B: Patients who will proceed into debulking surgery based on VATS finding. | Patients will be considered to be eligible for complete debulking, if VATS showed no intrathoracic tumor or if VATS achieves complete removal of tumor nodules through intraoperative frozen section histopathological examination. Receives: Procedure: VIDEO-ASSISTED THORACOSCOPIC SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of intrathoracic disease using chest-CT results compared to the standard reference results using VATs
Comparison between the Chest-CT results in preoperative evaluation of supra-diaphragmatic disease will be compared to the intra-operative VATS evaluation results to evaluate the role of the VATS in those patients
Measured: 3 weekS
Secondary outcomes (1)
The rate of change in the treatment plan according to VATs results
The number of patients that will receive different treatment plan after detection of intrathoracic disease using VATs
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2021
- Primary completion30 Jan 2023
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840029
- Sponsor's protocol ID
- VATS and ovarian cancer
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ROLE OF VIDEO-ASSISTED THORACOSCOPIC SURGERY IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES
- ClinicalTrials.gov ID
- NCT05840029
- Acronym / sponsor ID
- VATS and ovarian cancer
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer stage III, IV; VATS, CT staging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 3 May 2023 (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.
Ovarian cancer is the seventh most common cancer and the fifth leading cause of death in women worldwide.
About 70% of patients with epithelial ovarian cancer present with advanced disease which will require a combination of cytoreductive surgery and chemotherapy to give them their best chance of long term survival.The presence of macroscopic pleural disease-especially if undetected and unresected after primary debulking surgery-may alter treatment decision-making and markedly affect survival. Video-Assisted Thoracoscopic Surgery (VATS) allows surgeons, through a minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.
Few studies reported that VATS altered the therapeutic management in ovarian cancer patients leading to an upstaging or down-staging when compared to the CT staging. Therefore, this study will prospectively assess the role of VATS in the diagnosis and management of supradiaphragmatic disease as well as evaluate the impact of VATS findings on the decision of surgical management in patients with advanced ovarian cancer FIGO (The International Federation of Gynecology and Obstetrics) stage III/IV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Patients who will get neoadjuvant chemotherapy based on VATS finding. | – | Procedure: VIDEO-ASSISTED THORACOSCOPIC SURGERYPatients will be considered to receive neoadjuvant chemotherapy if there is residual intrathoracic disease |
| Group B: Patients who will proceed into debulking surgery based on VATS finding. | – | Procedure: VIDEO-ASSISTED THORACOSCOPIC SURGERYPatients will be considered to be eligible for complete debulking, if VATS showed no intrathoracic tumor or if VATS achieves complete removal of tumor nodules through intraoperative frozen section histopathological examination. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced ovarian cancer at gyneoncology department will be enrolled
Key inclusion criteria (1 listed)
- FIGO stage III/IV ovarian cancer with or without pleural effusion
Key exclusion criteria (5 listed)
- Previously treated ovarian disease.
- Patient unfit for single lung ventilation.
- Patients with previous lung surgery.
- Patients with possible intrapleural adhesions.
- Patients who had pulmonary resection.
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 |
|---|---|---|
| VIDEO-ASSISTED THORACOSCOPIC SURGERYAlso: VATSA minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor. | Procedure or surgery | Group A: Patients who will get neoadjuvant chemotherapy based on VATS finding., Group B: Patients who will proceed into debulking surgery based on VATS finding. |
Primary outcome
Prediction of intrathoracic disease using chest-CT results compared to the standard reference results using VATs
Time frame: 3 weekS
Comparison between the Chest-CT results in preoperative evaluation of supra-diaphragmatic disease will be compared to the intra-operative VATS evaluation results to evaluate the role of the VATS in those patients
1 secondary outcome
The rate of change in the treatment plan according to VATs results
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ovarian Cancer, run by Alexandria 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 5 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 3 May 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of intrathoracic disease using chest-CT results compared to the standard reference results using VATs (time frame: 3 weekS). 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 3 May 2023.