Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

This arm will be subject to Caris Molecular profiling.

Diagnostic analysis

Geoff Hall, PhD FRCP

This is a pilot feasibility study assessing the use of a commercial molecular profiling service in the UK's National Health Service (NHS). The impact of knowledge of a patient's molecular profile, and the time it takes to generate this knowledge, will be assessed by analysis of changes in physicians' treatment decisions prior to and following generation of a patient's molecular profile. Implications for benefit with therapies recommended by the profile will also be assessed and the following treatment outcomes collected: best response (based on routine clinical, radiological and biochemical assessment), progression free survival ratio (post Caris Molecular profiling versus prior treatment) and overall survival.

The concept of molecular profiling leading to personalised medicine is based on the hypothesis that using treatments selected by a molecular profiling approach favourably changes the clinical course for an individual patient. In order to best determine the next steps in a particular patient's clinical course, it is necessary to understand not only how that patient has been diagnosed, treated and responded to treatment in the past, but also to fully characterize the molecular profile of the patient's tumour, so that the maximum information on potential positive and negative treatment outcome can be gathered.

In this pilot feasibility study, the treatment plans devised for individual patients by their treating oncologists will be assessed. The primary endpoint is the frequency at which the oncologist changes a treatment plan based on the tumour's molecular phenotype and the respective drugs considered to be associated with higher likelihood of benefit or lack of benefit. Ultimately however, the treatment decision remains in the hands of the treating physicians and the study protocol does not prescribe or dictate the use of any particular treatment.

In patients with recurrent ovarian cancer or other gynecological malignancies in which no standard of care is defined, treatments are currently chosen empirically based on population-based response rates. With the use of molecular profiling treating physicians will get a chance to revise their treatment plans and consider the individual molecular profile of each patient's tumour in light of the known predictive power of biomarkers for the efficacy of certain drugs.

LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer

LCC-CARIS-01: A Pilot Feasibility Study to Assess the Use of Molecular Profiling to Determine Choice of Treatment for Patients With Gynecological Cancer

National Health Service, United Kingdom

Geoff Hall

Lead Clinical Investigator

Blood and Lymph Conditions

Uterine Cervical Neoplasms

Lymphedema

Vulvar Neoplasms

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Lymphatic Diseases

Vulvar Cancer

Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina

Patients without malignant gynaecological cancers

Andreas Obermair, MD FRANZCOG CGO

This project will conduct a prospective, longitudinal, observational cohort study to assess the onset and incidence of lymphoedema, as well as investigate factors associated with its development among women newly diagnosed with gynaecological cancers in 2008 to 2011.

Pathological swelling of the lower limbs (lymphoedema) is widely accepted to be a common consequence of treatment for gynaecological cancer. It is both a serious and debilitating complication, associated with significant morbidity, which impacts physically and emotionally on otherwise healthy women. Lymphoedema can also affect patients' ability to earn an income, especially if their work requires prolonged periods of standing or walking.

The causes of lymphoedema are largely unknown with clinical data scarce regarding its onset time and incidence after gynaecological cancer treatment.

The following hypotheses will be tested to address the aims of the project:

1. At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
2. Patient's age, as well as their body mass index (BMI), area of residence, degree of physical exercise, type of disease (uterine, cervical, ovarian, vulval/vaginal cancer; benign disease), mode of treatment (extent of lymph node dissection, radiotherapy, chemoradiation) and delay in wound healing are independent risk factors for lower-limb lymphoedema.
3. Patients who develop lymphoedema after gynaecological cancer treatment, will experience increased pain, lower quality of life (including worse body-image), and decreased sexual \& financial well-being, compared to those who do not develop lymphoedema.
4. There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.

Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

The University of Queensland

Royal Brisbane and Women's Hospital

Mater

Mater Private Hospital

Queensland Institute of Medical Research

Queensland University of Technology

Australia New Zealand Gynaecological Oncology Group

Cancer Australia

Queensland Centre for Gynaecological Cancer

Symptoms and General Pathology

Syndrome

Hemorrhage

Infertility

Postpartum Hemorrhage

Obstetric Labor Complications

Puerperal Disorders

Uterine Hemorrhage

Kuster Syndrome

Rokitansky Sequence

Catastrophic Antiphospholipid Syndrome

Benjamin Jones, MRCOG

Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors

INvestigational Study Into Transplantation of the Uterus

Oxford University Hospitals NHS Trust

Imperial College Healthcare NHS Trust

Womb Transplant UK

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Transgender population in France, male to female and female to male.

A flyer with QR code leading to the online questionnaire will be sent to trans associations and healthcare networks for distribution to the target population.

Questionnaire

Virginie GROUTHIER, MD

Clara GUINARD

To date, the transgender population, still poorly characterized, tends to increase. The impact of gender-affirming hormone therapy (GAHT) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. A recent literature review by a French team suggests gynecological follow-up procedures for transgender people.

The hypothesis of this study is that transgender population in France does not have appropriate gynecological care, and the study would like to find out, directly from the people concerned, the current state of gynecological care for transgender people in France. To do this, ths study plan to send out a questionnaire to transgender people (via healthcare networks and also transgender associations) to ask them about their actual gynecological care and their knowledge of recommended gynecological care.

The aim is to set up a descriptive, declarative study based on a questionnaire created specifically for this work.

This project will use a questionnaire for transwomen people and another one for transmen people. Transgender people will be approached via Trans associations and healthcare networks. An online link to the questionnaire will be sent to trans associations and healthcare networks for distribution to the target population thanks to a flyer.

Gynaecological Care for Transgender People in France in 2024.

Percentage of transgender people who know regular gynaecological recommendations in France, thanks to a homemade questionnaire

Overview of organized screening for gynaecological cancers and prostate cancer in the transgender population, thanks to a homemade questionnaire

Overview of knowledge about contraception in the transgender male population,thanks to a homemade questionnaire.

Overview of knowledge about fertility and the impact of hormone treatments in the transgender population, thanks to a homemade questionnaire.

Overview of our knowledge of the gynaecological repercussions of masculinizing hormone treatment in the transgender male population, thanks to a homemade questionnaire.

University Hospital, Bordeaux

Laparoscopic Assisted Vaginal Hysterectomy

Abhilasha Agarwal, MS

Minilaparotomy hysterectomy (MLH) relies on the simplicity of traditional open technique of abdominal hysterectomy, imparts cosmesis and faster recovery of laparoscopic hysterectomy yet avoids the long learning curve, cost of expensive setup and instrumentation associated with the minimally invasive approaches namely laparoscopy and robotics. In the present study, we tried to ascertain if the results obtained with MLH can be compared to LAVH in terms of its feasibility, intraoperative variables, and complications. The null hypothesis was that both MLH and LAVH are comparable techniques, so where cost and surgeon's experience are the confining issues, patients can be reassured that MLH gives comparable results.

Around 600,000 hysterectomies are performed every year in the United States, making hysterectomy the second most common surgery for women, first being cesarean section. Most of the hysterectomies are done for non cancerous conditions. And the most common indication for the same is symptomatic fibroid uterus.

In spite of being the most common gynaecological surgery the route of hysterectomy has always been an issue of debate since early 19th century. In the beginning it started as vaginal hysterectomy which soon was taken over by laparotomy route. With the advent of laparoscopy as the recent minimally invasive route the choices have further increased. Laparoscopic route has prompted the need for development of other forms of hysterectomy which are minimally invasive and are associated with less perioperative morbidity with better postoperative outcomes. Abdominal route includes both conventional and minilaparotomy; laparoscopic route includes both Laparoscopic Assisted Vaginal Hysterectomy (LAVH) as well as Total Laparoscopic Hysterectomy (TLH). Each method has its own advantages and disadvantages. The vaginal route is preferable because it is associated with less perioperative morbidity and faster recovery. Although laparoscopic route offers minimally invasive alternative to abdominal hysterectomy when vaginal route is contraindicated (In case of huge fibroid uterus or patients with pelvic pathology), it has its own drawbacks. The laparoscopic instruments are costly, there is a long learning curve involved in the training, and the operating time with this route is prolonged.

The EVALUATE study suggested that majority of surgeons(67%) preferred abdominal approach as the route of surgery, especially when dealing with pelvic pathology. Hence, minilaparotomy hysterectomy as an alternative minimally invasive surgery method was started. It relies on traditional open techniques and inexpensive instrumentation, making it significantly faster than laparoscopy and easy to perform. Hoffman et al found minilaparotomy hysterectomy procedure effective and safe in non-obese women in whom vaginal approach was contraindicated. Fanfani et al did a retrospective analysis on 252 patients who underwent minilaparotomy hysterectomy and found it to be a feasible route of surgery in benign gynaecological conditions with operative time similar or shorter as compared to vaginal, laparotomy and laparoscopy surgery. Few surgeons have modified the incision depending on the their experience which led to development of Pelosi method of Minilaparotomy Hysterectomy in 2003.

The final choice of the route and method depends on multiple factors which include indication of surgery, size of fibroid, equipments available in the surgical set up, surgeons' expertise, patient's financial background.

All patients followed the same standard pre-operative protocol. All surgeries were performed under general anesthesia with endotracheal intubation. Demographic details that included age, parity, body mass index (BMI), baseline investigations, diagnosis, and co-morbidities, were collated a day prior to the day of surgery. On admission, patients were informed in detail about the operation modalities and the associated complications. Patients along with their relatives were counselled about the advantages and disadvantages of both the surgical methods and the final decision was made on a joint consensus between the surgeon and the patient, following which an informed written consent was obtained.

The aim of the study was to compare the feasibility of two minimally invasive surgical procedures in low resource settings (such as India) - Laparoscopic assisted vaginal hysterectomy (LAVH) and Minilaparotomy hysterectomy (transverse suprapubic incision \<7cm).

Comparative Study of LAVH and Minilaparotomy Hysterectomy

Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions

All IPD that underlie results in a publication maybe shared after sponsor approval. Present status - undecided.

Weight and height will be combined to report BMI in kg/m\^2

All surgeries were performed by two gynecologists with an almost equal level of surgical competence.

Total amount of blood loss was calculated during both the methods. It was calculated by adding up the mop count (one fully soaked mop \~ 50 ml of blood loss) and the amount of fluid in the suction pump minus the saline used for irrigation.

There are various methods to score pain. In our study, we used visual analogue scale for the scoring. The pain was scored every 6th hourly for the first 24hrs and thereafter 24th hourly till 72 hrs.

The Visual Analogue Scale (VAS) (Figure 14) is a scoring scale on which the patient rates his/her pain on a scale of 0 to 10, 0 representing no pain and 10 representing excruciating or intolerable pain. The scoring is subjective and gives the patient freedom to choose the intensity of the pain as per their perception.

Visceral injury such as bladder/ ureter / bowel injury

Secondary haemorrhage, Urinary Tract Infection, Urinary retention, Wound infection, Thrombo-embolic complications, Febrile morbidity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer	NCT02668913	Epithelial Ovar... Peritoneal Canc... Fallopian Tube ... Gynaecological ...	Diagnostic anal...	18 Years -	University of Leeds
LCC-CARIS-01: Molecular Profiling in Gynaecological Cancer	NCT02668913	Epithelial Ovar... Peritoneal Canc... Fallopian Tube ... Gynaecological ...	Diagnostic anal...	18 Years -	University of Leeds
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer	NCT00604994	Female Genital ... Ovarian Cancer Cervical Cancer Endometrial Can... Vulval Cancer		18 Years -	Queensland Centre for Gynaecological Cancer
INvestigational Study Into Transplantation of the Uterus	NCT04244409	Mayer-Rokitansk... Asherson's Synd... Postpartum Hemo... Cervical Cancer		24 Years - 38 Years	Womb Transplant UK
Gynaecological Care for Transgender People in France in 2024.	NCT06357130	Transgender Man...	Questionnaire	18 Years -	University Hospital, Bordeaux
Comparative Study of LAVH and Minilaparotomy Hysterectomy	NCT03548831	Hysterectomy Minimal Invasiv... Benign Gynecolo...		-	Manipal University
Gynaecological Care for Transgender People in France in 2024.	NCT06357130	Transgender Man...	Questionnaire	18 Years -	University Hospital, Bordeaux
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer	NCT00604994	Female Genital ... Ovarian Cancer Cervical Cancer Endometrial Can... Vulval Cancer		18 Years -	Queensland Centre for Gynaecological Cancer

Spots Global Cancer Trial Database for gynaecology

Every month we try and update this database with for gynaecology cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gynaecology

Every month we try and update this database with for gynaecology cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gynaecology cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.