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70 active trials for Gynecologic Cancer

TH1902 in Patients With Advanced Solid Tumors

Open label first-in-human study of TH1902 in solid cancer, with 2 sequential parts: Part 1 (dose escalation): patients with recurrent advanced solid tumors (all comers) that have relapsed or are refractory to standard chemotherapy, surgery, radiation therapy, and for which no known effective therapies exist. Part 2 (expansion): selected patient populations with recurrent advanced TNBC, gynecological cancer (epithelial ovarian or endometrial cancer), colorectal cancer and pancreatic cancer that have relapsed or are refractory to standard chemotherapy, surgery, radiation therapy, and for which no known effective therapies exist.

Start: March 2021

Patient Related Outcomes for Gynecologic Radiation Oncology

The goal of this study is to see if it is feasible to use electronic questionnaires to measure patient related outcomes before, during, and after radiation for gynecologic cancer in a high-volume radiation oncology clinic.

Start: May 2021

Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer

The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.

Start: November 2017

poStoperative Anesthesia Care: Facial Mask vs Hfnc and Thoracic Ultrasound for Reduction of Atelectasis Incidence

The primary aim of this study is to assess the efficacy of post-operatory HFNC in reducing the incidence of hypoxemia after gynecological oncology surgery, compared to the standard application of O2 through a Venturi mask; The secondary objectives are to investigate the occurrence and entity of lung atelectasis, to evaluate diaphragmatic function and respiratory discomfort, and to evaluate the incidence of respiratory complications after seven days in the two groups. Patients will be randomized into two groups: HFNC and Control. The patients will be studied with preoperative lung and diaphragmatic ultrasound. Standard general anesthesia will be administered in the two groups. Ultrasound will be performed at arrival in the recovery room (RR) and before discharge from the RR. In the HFNC group, high-flow O2 will be administered; in the control group standard O2 therapy with Venturi mask will be administered. Arterial blood gas analysis upon arrival in the RR and after two hours of O2 therapy in both groups will be checked. The incidence of post-operative respiratory complications will be monitored in the seven days following surgery.

Start: October 2020

Risk Stratified Multidisciplinary Ambulatory Management of Malignant Bowel Obstruction in Gynecological Cancers

Management of Malignant Bowel Obstruction (MBO) in Patients with Advanced Gynecological Cancers

Start: August 2017

Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact

Our objective is to initiate an exercise program for patients with advanced GI or Gyn cancer, as prehabilitation prior to surgery. The objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. The prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC)

Start: March 2021

Mindfulness in Endometrial and Cervical Cancer

Patients with endometrial cancer who will be undergoing surgery or patients with cervical cancer who will be treated with chemoradiation will be randomized to utilize the Headspace smartphone application or not prior to their anticipated treatment.

Start: July 2020

GO SOAR1: Post-Operative Morbidity and Mortality Following Gynaecological Oncology Surgery

The Global Gynaecological Oncology Surgical Outcomes Collaborative (GO SOAR) will develop a network of gynaecological oncology surgeons, surgical departments and other interested parties that will have the long-term ability to collaborate on outcome studies. The aims of the Collaborative are to: Set the research agenda through research prioritisation in gynaecological oncology surgical outcomes. Gather high quality data via a centralised database accessible to all sites that perform gynaecological oncology surgery. Build sustainable international research by producing protocols/guidelines. Train the researchers and leaders of tomorrow by providing open access to all GO SOAR training materials. The Collaborative will lead to several studies. The first GO SOAR collaborative study (GO SOAR1) will evaluate international variation of post-operative morbidity and mortality following gynaecological oncology surgery between country groups defined by the human development index (HDI).

Start: January 2021

Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.

This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.

Start: February 2021

Study on TIL for the Treatment of r/r Gynecologic Tumors

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gynecologic tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.

Start: January 2021

Quality of Life After Robotic Surgery for Endometrial Cancer

The purpose of this study is to investigate how robotic assisted laparoscopic surgery affects the quality of life of women who are treated with primary surgery for endometrial cancer. So far, very little has been published and basically no long-term follow-up. Included patients respond to questionnaires preoperatively, 2 weeks after surgery and 3 months and 12 months after surgery. Each patient thus answers the questionnaires (the same) on four occasions. The questionnaires used are validated and used extensively internationally. The first survey has two parts, QLQ30 and the module for endometrial cancer EN24. In addition the study includes use PHQ -9 and GAD 7.

Start: June 2019

Hypotension Prediction With HPI Algorithm During Major Gynecologic Oncologic Surgery

Intraoperative hypotension (IOH) is a rather common event during general surgery, with variable incidence that ranges between 5 and 99% based on the definition used. It is associated to significant complications including acute renal failure, myocardial damage, stroke and overall increased mortality, reason why the prevention and the reduction of hypotensive events through an appropriate proactive approach can potentially improve the patient's outcome. The Hypotension Prediction Index (HPI) is an algorithm derived from the analysis of the arterial waveform and it is expressed as an absolute value from 0 to 100. It has been demonstrated that the HPI is able to predict the occurrence of hypotensive events of patients undergoing major surgery under general anesthesia, providing also a guide for the appropriate treatment based on further calculated secondary hemodynamic variables that estimate patient's preload, cardiac contractility and afterload. Aim of this prospective randomized study is to compare the incidence of IOH during major gynecologic oncologic surgery among two groups of patients receiving standard hemodynamic monitoring versus HPI monitoring. The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of intraoperative hypotensive events, defined as mean arterial pressure (MAP) lower than 65 mmHg lasting more than one minute.

Start: October 2020

Bone Toxicity Following Pelvic Radiotherapy

A randomised controlled clinical feasibility trial to determine the feasibility and acceptability of a "musculoskeletal health package (MHP)" intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and inform power calculations for a definitive trial.

Start: April 2021

Yoga for Psychological Distress in Gynecologic, Gastrointestinal, or Thoracic Cancer

This study will test the feasibility and acceptability of a yoga program for women with gynecologic, gastrointestinal (GI), or thoracic malignancies. This study will pilot an integrative yoga intervention that combines Western psychotherapeutic approaches with classic yogic philosophy to reduce emotional distress among women undergoing treatment for gynecologic, gastrointestinal (GI), or thoracic cancer and provide a comprehensive approach to stress management across the cancer care continuum.

Start: February 2018

Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer

Circulating tumor DNA (ctDNA) offers the possibility of accessing the tumor genome from circulating blood through a simple blood test. It is currently used for diagnostic, prognostic and predictive purposes of response or resistance to oncological treatments. These advances in ctDNA have been made possible by major developments in molecular biology techniques in recent years, as the detection of ctDNA requires very sensitive techniques such as Next Generation Sequencing (NGS). CtDNA overcomes this problem of very limiting tumor heterogeneity during a solid biopsy. All of these applications make circulating DNA an increasingly essential tool in the management of cancer patients. The studies are currently in most cases on small numbers and are retrospective. In addition, exosomes are also a biomarker of the future that can also be detected in the bloodstream . Exosomes are nanovesicles 50 to 200 nm in diameter released into the extracellular environment via the endosomal pathway by fusion with the plasma membrane. They are very informative since they transport tumor genetic material in the form of DNA, mRNA and miRNA, but also adhesion proteins, immunostimulatory molecules and cytoskeleton, enzymes and Heats shock proteins ( HSP). The aim of the ADIGYN study is to set up a large prospective cohort to assess the diagnostic, prognostic and predictive impact of ctDNA and exosomes in digestive and gynecological / breast cancers. From the circulating DNA, we characterize the ActDNA on the molecular level thanks to the study of different point mutations usually used but also of new described mutations having a therapeutic impact and the search for other genetic alterations having an impact on the therapeutic strategy (such as microsatellite instability) or the study of exosomes and their composition. To assess resistance to oncological treatments, ctDNA will be analyzed at the start of treatment, during treatment, during progression and / or relapse and also during monitoring or treatment break

Start: January 2021

Using Pedometers for the Assessment and Enhancement of Mobility in Gynaecological and Oncological Patients Following Surgery.

This is a prospective cohort study, planned to study the effects of pedometers (digital step counters) on patient mobility following gynecology and gynecology oncology surgeries. The investigators plan to study the effect of personalized repeated feedback approach based on pedometer results in patients following gynecology and gynecology oncology surgeries.

Start: May 2020

Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy Cancer

The aim of this study is to evaluate the effect of cryocompression therapy on the incidence and degree of taxane-induced peripheral neuropathy in gynecologic cancer patients receiving chemotherapy. Subjects will serve as their own controls, and will be randomized to cryocompression therapy on their dominant versus non-dominant hand and foot, with standard of care treatment (no intervention) on the opposite hand and foot. Compression therapy will be performed using commercially available compression socks and disposable surgical gloves, and cryotherapy will be achieved by applying bags of ice to the compression devices. Subjects will complete baseline neuropathy surveys including the Patient Neurotoxicity Questionnaire (PNQ) and the Functional Assessment of Cancer Therapy (FACT) -Taxane (FACT-NTX), which includes the sensory subscale of the FACT-NTX. Subjective symptoms will be assessed at baseline, before each cycle of chemotherapy and cryocompression, and one month after completion of 6 cycles. In addition, tactile sensation will be assessed with the monofilament test at baseline and one month after completion of 6 cycles of chemotherapy and cryocompression. The primary outcomes are the proportion of patients with PNQ grade C or higher and decline in tactile sensitivity from baseline based on the monofilament test. The investigators hypothesize that cryocompression will reduce chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer.

Start: January 2021

Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

The purpose of this study is to incorporate feedback from cancer patients and providers to adapt, implement, and test an intervention. The intervention aims to prompt screening for financial distress, facilitate discussions about care costs with cancer patients, support health insurance selection, and ultimately reduce cancer patients' financial toxicity associated with cancer care.

Start: May 2020

Evaluation of a Brachytherapy Discharge Education Program to Improve Patient Care

Although brachytherapy is an effective treatment modality for gynecological cancer, a significant proportion of patients develop late treatment-related vaginal toxicity, negatively impacting their quality of life and limiting recurrent disease detection by preventing adequate clinical examination during the post-treatment surveillance period. Consistent with the literature, results from a study at Princess Margaret revealed that current vaginal toxicity management education and training may be inadequate. The investigators seek to implement and evaluate a new online brachytherapy discharge education program (BrachDEP) to support patient engagement in self-management.

Start: August 2020

Clinical Value of Molecular Genetic Analyzes in Gynecological Malignomas

The aim of the planned research project is to find out the clinical significance of molecular genetic analyzes in gynecological malignomas. In particular, it will be investigated how the knowledge of a molecular-genetic finding affects the therapeutic decision of the physician. Furthermore, genetic changes in the tumor tissue will be compared with the changes in CTCs, DTCs and cfDNA.

Start: May 2017