Optical Biopsy and Fallopian Tube (NCT02365779) | Clinical Trial Compass
CompletedNot Applicable
Optical Biopsy and Fallopian Tube
France40 participantsStarted 2015-01
Plain-language summary
High-grade serous ovarian cancer is the most threatening type of gynaecological cancer with an important mortality due to late diagnosis. However the prognosis is excellent in the early stages of the disease. Recently it has been described a new serous carcinogenic sequence from the fallopian tube with tubal precancerous lesions. Therefore the identification of these early preinvasive lesions would be of great interest in the population with hereditary predisposition for ovarian cancer (concept of oncofertility) and in the general population (to determine whether bilateral salpingectomy has to be performed during a hysterectomy for benign disease).
The optical biopsy has been developed and validated in the detection of early precancerous lesions (such as Barrett's oesophagus or in situ cancer of the bladder). The first objective of this study is to prospectively assess the efficacy of optical biopsy (Cellvizio®) in the study of fallopian tubes during laparoscopy with correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation. The second objective is to describe the optical biopsy pictures in order to state a classification.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Woman aged 18 years or more
* All patients with laparoscopic salpingectomy for benign conditions (tubal ligation, during a hysterectomy), for prophylactic conditions (BRCA mutation) or in case of pelvic cancers
* Informed and signed consent
Exclusion Criteria:
* Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* Pregnancy, ongoing or planned during the study period
* Allergy to fluorescein
* Previous allergy or anaphylactic shock during an angiography
* Allergic or hypersensibility reactions
* Severe asthma, chronic cardiac or pulmonary diseases
* Restricted renal function
* Patient under a beta-blockers treatment
* Inability to understand information provided
* Not covered by a national health insurance scheme, prisoner or under administrative supervision
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a technique called endomicroscopy to examine fallopian tubes during laparoscopic salpingectomy — can you explain what endomicroscopy actually involves and whether it would have changed anything about how my surgery is done?
2Since this study compared endomicroscopy images with traditional lab analysis of tissue samples, what did research like this find about how well the two methods agreed, and does that affect how my fallopian tube tissue would be examined if I have a salpingectomy?
3This trial is now completed — are the findings from it influencing the way you currently perform or interpret results from a bilateral laparoscopic salpingectomy, or is this still considered experimental practice?
4The study focused on analyzing fallopian tube tissue at a microscopic level during surgery — is there anything about my specific situation that would make this kind of detailed tissue examination particularly important for my care?
5Given that this was essentially a diagnostic or observational study rather than a treatment trial, how does the information gathered here fit into the bigger picture of what we know about why salpingectomy might be recommended for someone like me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between the histopathological and immunohistochemical analysis and the endomicroscopy image interpretation