Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-30 @ 5:20 PM
Study NCT ID:
NCT01548105
Status:
COMPLETED
Last Update Posted:
2014-10-17
First Post:
2012-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-15', 'studyFirstSubmitDate': '2012-03-04', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism.', 'timeFrame': 'One day- day of blood draw', 'description': 'These will include blood levels of the following:\n\n* Procollagen 1-N propeptide levels (PINP)\n* Matrix metalloproteinase (MMP9)\n* Plasma Vitamin C levels'}], 'secondaryOutcomes': [{'measure': '• A secondary objective will be to determine whether women with pelvic organ prolapse are different than healthy controls with respect to the same systemic markers', 'timeFrame': 'One day- day of blood draw'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pelvic organ prolapse', 'smoking and collagen metabolism'], 'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': "Data on smoking and POP are conflicting. In a study done by Alnaif et al, smoking was found to be associated with severe POP. The authors' proposed explanation was that smoking impairs tissue and wound healing. Our primary objective is to document whether smokers with pelvic organ prolapse (POP) are different from non-smokers with POP with respect to collagen biosynthesis and breakdown using systemic markers of collagen metabolism and Vitamin C.", 'detailedDescription': 'Tissue destructive disorders are more common in smokers than in non-smokers. Alterations in wound healing and connective tissue turnover are suggested mechanisms, but exact details remain to be discovered. The synthesis of subcutaneous collagen in smokers is specifically impeded, and that smokers have less collagen compared to non-smokers. Jorgensen et al study showed that smokers tend to have less procollagen I N-propeptide (PINP) levels in the blood, less vitamin C and higher levels of matrix metalloproteinase (MMP-9), these findings reversed after smoking cessation.\n\nSince smoking is one of the promoting and modifiable factors in the development of prolapse, understanding its effects on the support of pelvic organs may help modify the course of the POP condition in the future. Understanding the connective tissue effects of smoking using systemic markers of collagen metabolism in female smokers with prolapse may help future management and counseling of these patients. In addition, description of the markers of collagen metabolism in POP has not previously been documented.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pelvic organ prolapse and without prolapse will be identified based on a manual review of patients in a tertiary care referral-based Urogynecology practice', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: PROLAPSE group\n\n* More than 18 years old\n* Symptomatic POP at or beyond the hymen as determined by physical examination and a positive answer to the screening questions\n* For smoker group- smoke more than one pack per day\n* For non smoker group- non smoker for more than 7 years\n\nNo Prolapse group:\n\n* Absence of prolapse and negative answer to the screening questions\n\nExclusion Criteria:\n\n* Using Hormone Replacement Therapy (systemic estrogen, progesterone or testosterone)\n* Using vaginal estrogen (cream, ring, tablet)\n* Chronic steroid use\n* Past medical history of connective tissue disease\n* Scurvy, malabsorption, alcoholism, pregnancy, hyperthyroidism, liver disease and renal failure'}, 'identificationModule': {'nctId': 'NCT01548105', 'briefTitle': 'Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Systemic Markers of Collagen Metabolism and Vitamin C in Smokers and Non-Smokers With Pelvic Organ Prolapse', 'orgStudyIdInfo': {'id': 'Smoking and prolapse'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prolapse and Smoker', 'description': 'Patients in this arm have been determined to have more than stage 2 pelvic organ prolapse and have been smoking more than one pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels', 'interventionNames': ['Other: Blood draw for the study participants']}, {'label': 'Prolapse and non smoker', 'description': 'Patients in this arm have been determined to have more than stage 2 pelvic organ prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels', 'interventionNames': ['Other: Blood draw for the study participants']}, {'label': 'No prolapse and smoker', 'description': 'Patients in this arm, have been determined not to have prolapse and smokes more than 1 pack per day Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels', 'interventionNames': ['Other: Blood draw for the study participants']}, {'label': 'No prolapse and non smoker', 'description': 'Patients in this arm have been determined not to have prolapse and non smoker for more than 7 years Blood draw for the study participants will be done. These will include: Procollagen 1-N propeptide levels (PINP), Matrix metalloproteinase (MMP9) and Plasma Vitamin C levels', 'interventionNames': ['Other: Blood draw for the study participants']}], 'interventions': [{'name': 'Blood draw for the study participants', 'type': 'OTHER', 'description': 'These will include:\n\n* Procollagen 1-N propeptide levels (PINP)\n* Matrix metalloproteinase (MMP9)\n* Plasma Vitamin C levels', 'armGroupLabels': ['No prolapse and non smoker', 'No prolapse and smoker', 'Prolapse and Smoker', 'Prolapse and non smoker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Maria Victoria C Estanol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Good Samaritan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}