Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-26 @ 11:33 PM
Study NCT ID:
NCT01098292
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2010-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Control Participants for the MAPP Research Network
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA Blood Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 615}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2010-04-01', 'studyFirstSubmitQcDate': '2010-04-01', 'lastUpdatePostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline outcome measures', 'timeFrame': 'Baseline', 'description': 'Extensive data on risk factors and outcomes measures will be collected for the Trans-MAPP Control Study. These measures can be classified into a number of primary domains as described below.\n\n1. General Measures of Sociodemographics, Health, and Quality of Life\n2. UCPPS Symptoms Measures\n3. Non-urological Symptom Measures\n4. Trait-like Personal Factors\n5. Biological Specimens'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Irritable Bowel Syndrome', 'Chronic Fatigue Syndrome', 'Interstitial Cystitis', 'Chronic Prostatitis', 'Urological Chronic Pelvic Pain', 'Painful Bladder Syndrome'], 'conditions': ['Fibromyalgia', 'Irritable Bowel Syndrome', 'Fatigue Syndrome, Chronic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://mappnetwork.org', 'label': 'MAPP Research Network Website'}]}, 'descriptionModule': {'briefSummary': 'The Control Study for the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken.\n\nParticipants with no Urologic Pelvic Pain Syndromes as well as participants with specific conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome (CFS)) are being recruited for the Trans-MAPP Control Study. These participants will act as a reference/control group for the Trans-MAPP Epidemiology \\& Phenotyping (EP) Study.\n\nAs with many chronic pain disorders, IC and CP are poorly understood, and treatment is often not helpful. The goal of this study is to better understand how pain is felt in people with IC or CP. The MAPP Control Study is an observational study that will enroll participants from 6 Discovery Sites and 3 Satellite Sites across the U.S. The investigators will ask questions and gather information about the health and life of the participants for research purposes. The investigators hope that this study will lead to improvement in the treatment of IC and CP.', 'detailedDescription': 'Trans-MAPP Control participants will only need to complete one study visit to collect baseline data and biospecimens. Potential participants will be scheduled for an eligibility screening session. Following screening, potentially eligible participants will complete a baseline phenotyping session, and biospecimen collections, which together are expected to take approximately 2.5 hours to complete. Participants will be provided with breaks as needed during the clinic visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Trans-MAPP Control Study population will include adult participants, at least 18 years of age, with no urological chronic pelvic pain syndromes. These participants will fall into two categories: Healthy Controls and Positive Controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'The eligibility criteria for both healthy controls and positive controls are based on the same set of criteria for the Urologic Chronic Pelvic Pain Syndrome (UCPPS) participants in the Trans-MAPP EP Study, with exception of additional criteria to exclude chronic pelvic pain symptoms and criteria to identify the co-morbid syndromes for the positive controls. All entry criteria are shown below; those specific to either healthy or positive control participants are so indicated.\n\nInclusion Criteria:\n\nParticipants are eligible for the Trans-MAPP Control Protocol if they meet the following general and gender-specific criteria listed below:\n\n1. Participant has signed and dated the appropriate Informed Consent document.\n2. Agreed to participate in Trans-MAPP Control Study procedures;\n\nInclusion Criteria for Healthy Controls only\n\n1. Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale.\n2. Participant reports no chronic pain in the pelvic or bladder region, and reports chronic pain in no more than one other body region.\n3. Participant reports no urological symptoms that have been evaluated, but are still present.\n\nInclusion Criteria for Positive Controls only:\n\n1\\. Participant meets the validated criteria for one or more of the following conditions\n\n1. Fibromyalgia (FM)\n2. Irritable bowel syndrome (IBS)\n3. Chronic fatigue syndrome (CFS)\n\nExclusion Criteria:\n\nIndividuals will not be eligible for enrollment in the Trans-MAPP Control Study if they meet any of the criteria:\n\n1. Participant has an on-going symptomatic urethral stricture.\n2. Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.\n3. Participant has a history of cystitis caused by tuberculosis or radiation therapy or Cytoxan/cyclophosphamide therapy.\n4. Participant has augmentation cystoplasty or cystectomy.\n5. Participant has a systemic autoimmune disorder (such as Crohn\'s Disease, Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis).\n6. Participant has a history of cancer (with the exception of skin cancer).\n7. Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).\n8. Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.\n\nExclusion Criteria for Males Only\n\n1. Male participant diagnosed with unilateral orchialgia, without pelvic symptoms.\n2. Male participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, or prostate cryosurgery or laser procedure.\n\nExclusion Criteria for Females Only:\n\n1\\) Female participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL) / high-grade cervical dysplasia.'}, 'identificationModule': {'nctId': 'NCT01098292', 'acronym': 'MAPP-Control', 'briefTitle': 'Observational Study of Control Participants for the MAPP Research Network', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Control Study', 'orgStudyIdInfo': {'id': '810668'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control', 'description': 'Healthy Control participants do not suffer from any Urological Chronic Pelvic Pain Syndromes or from the following conditions:\n\nFibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome'}, {'label': 'Positive Control', 'description': 'Positive Control participants do not suffer from any Urological Pelvic Pain Syndromes like Interstitial Cystitis and/or Chronic Prostatitis. However Positive Controls have a history of one of the following conditions:\n\nFibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'J. Quentin Clemens, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan'}, {'name': 'Christopher Mullens, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}