Ovarian CancerNCT03235648
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer
A study testing cardiophrenic lymph nodes resection in people with Ovarian Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer 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?
- cardiophrenic lymph nodes resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Jun 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ovarian cancer patient (FIGO stage III-IV)
- Preoperative CT showing CPLN with short axis diameter > 5mm.
- Anathestically fit patient (ASA score I or II).
- Accepted pulmonary function test.
- Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled
- Written informed consent.
- Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )
Who cannot join
- Anathestically unfit patient
- Unresectable disease
- Patient refusal
- No detected CPLN by preoperative radiology
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Oncology center, Mansoura University
Cairo, Dakhlia, 35116
Basel R. Abdelfattah, MD,MRCS, 01001974340 ext. +2, dr.basel@hotmail.com
About this study
Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer
Read the detailed description
The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is still debatable , correlation of radiological finding with pathological findings after reaction of radiological positive lymph nodes and its impact in diseases free survival and over all survival
- Conditions
- Ovarian Cancer
- Being tested
- cardiophrenic lymph nodes resection
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiophrenic lymph nodes resectionProcedure or surgery
surgical resection
| Study group | Role | What they receive |
|---|---|---|
| cardiophrenic nodes excision in ovarian cancer | Experimental | We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes Receives: Procedure: cardiophrenic lymph nodes resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of CPN retrieved/pathological nodes
correlation of radiological active lymph nodes with pathological findings
Measured: up to 3 years
Secondary outcomes (1)
Progression free survival
2 years progression without disease recurrence
Measured: up to 2 years following the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Jun 2017
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 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 Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basel Refky, MD, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235648
- Sponsor's protocol ID
- R/17.05.162
- Status last verified
- Jul 2017
- First submitted
- 2 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03235648
- Acronym / sponsor ID
- R/17.05.162
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 1 Aug 2017 (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.
Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer
Detailed description
The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is still debatable , correlation of radiological finding with pathological findings after reaction of radiological positive lymph nodes and its impact in diseases free survival and over all survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiophrenic nodes excision in ovarian cancer | Experimental | Procedure: cardiophrenic lymph nodes resectionWe are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ovarian cancer patient (FIGO stage III-IV)
- Preoperative CT showing CPLN with short axis diameter > 5mm.
- Anathestically fit patient (ASA score I or II).
- Accepted pulmonary function test.
- Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled
Key exclusion criteria (4 listed)
- Anathestically unfit patient
- Unresectable disease
- Patient refusal
- No detected CPLN by preoperative radiology
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 |
|---|---|---|
| cardiophrenic lymph nodes resectionsurgical resection | Procedure or surgery | cardiophrenic nodes excision in ovarian cancer |
Primary outcome
number of CPN retrieved/pathological nodes
Time frame: up to 3 years
correlation of radiological active lymph nodes with pathological findings
1 secondary outcome
Progression free survival
Time frame: up to 2 years following the end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiophrenic lymph nodes resection in people with Ovarian Cancer, run by Mansoura 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 7 inclusion and 4 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 1 Aug 2017. 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 Basel R. Abdelfattah, MD, MRCS (01001974340 ext. +2, dr.basel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of CPN retrieved/pathological nodes (time frame: up to 3 years). 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 1 Aug 2017.