Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 12:55 AM
Study NCT ID:
NCT04402333
Status:
UNKNOWN
Last Update Posted:
2020-09-02
First Post:
2020-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tumour tissue samples from patients undergoing robotic interval debulking surgery and open interval debulking surgery. Analysis will involve primarily immunohistochemistry but may include extracting Ribonucleic acid (RNA).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-10-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': 'Assessed at 1 year (recruitment period)', 'description': 'Number of patients consented compared to the number identified by multidisciplinary team as eligible for inclusion in the study expressed as a percentage.\n\nSuccess criteria: At least 20% of people eligible for the study will accept inclusion in the study.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life following Surgery', 'timeFrame': '3 months post surgery', 'description': 'Assessed using European Organisation for Research and Treatment of Cancer (EORTC) Validated quality of life questionnaire (QLQ) for ovarian cancer (QLQ-C30/QLQ-OV28). This validated questionnaire consists of the core module and its associated ovarian cancer specific module.'}, {'measure': 'Mental wellbeing', 'timeFrame': '3 months post surgery', 'description': 'Hospital anxiety and depression scale (HADS) A (Anxiety) and D (Depression) scores are calculated separately. 0-7 = Normal, 8-10 = Borderline, 11-21 = Abnormal (case)'}, {'measure': 'Pain assessment', 'timeFrame': '3 months post surgery', 'description': 'Numeric rating scale (NRS11) 0 (no pain) - 10 (worst pain)'}, {'measure': 'Surgical complications', 'timeFrame': 'Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) (Quarterly reports to be submitted to sponsor)', 'description': 'Intraoperative complications will be recorded. Post operative complications will be recorded and classified by Clavien-Dindo Classification.\n\nSuccess criteria: Complication rate is not higher than for open interval debulking surgery'}, {'measure': 'Rate of Conversion to open surgery', 'timeFrame': 'Assessed at 1 year 3 months (once last recruited patient has undergone surgery)', 'description': 'Percentage of patients converted to open surgery after being deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy.\n\nSuccess criteria: Conversion to open surgery rate not greater than 50% in patient group deemed suitable for Robotic interval debulking surgery following initial diagnostic laparoscopy.'}, {'measure': 'Robotic interval debulking - Maximal Macroscopic debulking rate (R=0 rate)', 'timeFrame': 'Assessed at 1 year 3 months (once last recruited patient has undergone surgery)', 'description': 'Percentage of patients undergoing robotic interval debulking surgery who achieve Maximal macroscopic debulking i.e. no macroscopic residual disease present (R=0 rate)'}, {'measure': 'Overall Survival', 'timeFrame': 'Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years', 'description': 'Measured in Months from the date of surgery.\n\nIn order to follow up long-term survival in participants suffering from ovarian cancer and subsequently correlate this to the research findings it is necessary to store minimal personal data after completion of the study this is detailed in documentation submitted and approved by London - Riverside Research Ethics Committee.'}, {'measure': 'Progression free survival', 'timeFrame': 'Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period) reassessed at 5 years to maximum of 10 years', 'description': 'Measured in Months from the date of surgery until the date of first documented progression.\n\nIn order to follow up progression free survival in participants suffering from ovarian cancer and subsequently correlate this to the research findings it is necessary to store minimal personal data after completion of the study this is detailed in documentation submitted and approved by London - Riverside Research Ethics Committee.'}, {'measure': 'Cost', 'timeFrame': 'Assessed at close of trial - 15 months +/- 7 days (recruitment + follow up period period)', 'description': 'Cost of Robotic minimally invasive interval debulking surgery to the hospital compared to a similar open procedure measured in British Pound (GBP) £'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer', 'Ovarian Neoplasm', 'Ovarian Neoplasm Epithelial', 'Fallopian Tube Cancer', 'Peritoneal Cancer']}, 'descriptionModule': {'briefSummary': 'MIRRORS "Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery \\& Survival" is a new United Kingdom based prospective feasibility study the purpose of which is to establish the feasibility of launching a British multicentre randomised control trial of Robotic interval debulking surgery for ovarian cancer (including cancer of the fallopian tube \\& peritoneum) in the future. This initial feasibility study will focus on the ability to recruit patients, acceptability, quality of life, the rate at which it is possible to remove all visible tumour and the rate of conversion to open surgery. Ultimately the investigators would like to determine whether, in selected patients, robotic surgery offers improved quality of life and recovery with equivalent overall and progression free survival.\n\nRobotic surgery is unlikely to be suitable in all cases of ovarian cancer, particularly those with large pelvic masses or extensive disease around the upper part of the abdomen, however, it has the potential to provide significant recovery and quality of life benefits to a selected group of patients.\n\nMIRRORS - ICG "Peritoneal angiography / perfusion assessment using Indocyanine green (ICG) in patients with advanced ovarian cancers" is a ancillary study within MIRRORS. Using ICG dye, the investigators aim to observe whether there are any changes in the blood vessel pattern associated with the tumour deposits the investigators remove that makes them distinctive. The ICG will not be used to guide where biopsies are taken or tissue is removed. Participation in this ancillary research is not required for participation in the trial.', 'detailedDescription': 'Hypothesis: in selected cases of ovarian cancer, following neoadjuvant chemotherapy, minimally invasive robotic surgery provides maximal debulking surgery and improved patient outcomes.\n\nNull Hypothesis: Robotic surgery is not suitable for the treatment of ovarian cancer following neoadjuvant chemotherapy. It is not possible to achieve maximal debulking surgery and patient outcomes are not improved.\n\nTo assess the feasibility of obtaining consent from women and acceptability of Robotic interval debulking surgery for advanced ovarian cancer. Women deemed suitable for interval debulking surgery will be identified through the Gynaecological Oncology multidisciplinary team meeting. The aim is to recruit women over a period of 1 year aiming for a total of 20 women who undergo Minimally Invasive Robotic Interval debulking surgery for advanced ovarian cancer. The main outcomes are feasibility of the recruitment process and acceptability of the questionnaires and numeric rating pain scale (NRS11) as assessed by completion rate and patient interviews.\n\nIn order to be able to offer MIRRORS to as many patients as possible the investigators have kept the inclusion criteria wide, not restricting by Body Mass Index (BMI), patient comorbidities or Ca125 level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Suitable participants will be identified during the Royal Surrey NHS Foundation Trust Gynaecological Oncology multidisciplinary team meeting (MDT).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult women ≥18 years with Stage IIIc -IVb Ovarian cancer (including fallopian tube and peritoneal cancer) undergoing Neo-adjuvant Chemotherapy.\n\nConsidered suitable for Interval debulking surgery\n\n≤8cm pelvic mass\n\nMIRRORS ICG Inclusion Criteria - Same as above\n\nExclusion Criteria:\n\nPelvic mass \\>8cm, open surgical approach considered necessary following MDT review. Lacking capacity to the extent they are unable to understand or complete trial documentation / questionnaires.\n\nMIRRORS ICG Exclusion criteria will be:\n\nSevere renal insufficiency estimated Glomerular filtration rate (GFR)\\< 55ml/min, known allergy to iodine or Indocyanine green (ICG) and hyperthyroidism.'}, 'identificationModule': {'nctId': 'NCT04402333', 'acronym': 'MIRRORS', 'briefTitle': 'Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival', 'organization': {'class': 'OTHER', 'fullName': 'Royal Surrey County Hospital NHS Foundation Trust'}, 'officialTitle': 'MIRRORS: Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival', 'orgStudyIdInfo': {'id': 'MIRRORS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robotic interval debulking surgery', 'description': 'Surgery will commence with an initial assessment with a camera inserted though the belly button. This visual assessment will be used to determine whether it is feasible to proceed with surgery robotically or whether full debulking surgery to zero macroscopic residual disease would be best carried out through an open surgical approach. If an open surgical approach is considered the optimum treatment for the patient and they have consented for this, then this will be done. If there is disease that cannot be removed Robotically after starting by this route, but can be removed via an open incision the surgery will be converted to an open procedure if it is safe to do so. If there are any complications, we may also need to convert to open surgery. The aim of the surgery whether by robotic or open is to remove all visible disease safely.', 'interventionNames': ['Procedure: Robotic Interval Debulking Surgery']}, {'label': 'Open interval debulking surgery', 'description': 'Standard Care. Following initial laparoscopic assessment patients not deemed suitable for minimally invasive robotic surgery will proceed with standard open interval debulking surgery through an extended midline incision. These patients will also be followed up to assess recovery, complication rate and quality of life.'}], 'interventions': [{'name': 'Robotic Interval Debulking Surgery', 'type': 'PROCEDURE', 'description': 'Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.', 'armGroupLabels': ['Robotic interval debulking surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Christina M Uwins, MRCS, MRCOG', 'role': 'CONTACT', 'email': 'christina.uwins@nhs.net'}], 'facility': 'Royal Surrey NHS Foundation Trust', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'centralContacts': [{'name': 'Christina M Uwins, MRCS MRCOG', 'role': 'CONTACT', 'email': 'Christina.Uwins@nhs.net', 'phone': '07958143884'}, {'name': 'Kate Penhaligon', 'role': 'CONTACT', 'email': 'k.penhaligon@nhs.net', 'phone': '01483 688660'}], 'overallOfficials': [{'name': 'Simon Butler-Manuel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Surrey NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Surrey County Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}