Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06830551
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2025-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Cord Blood Serum Eyes Drops Administer in Patients With Severe Keratopathy Related to EGFR-I Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal damage measured with National Eye Institute (NEI) score', 'timeFrame': 'one week before the start of treatment and thirty days after the end of treatment.', 'description': 'Evaluation of the effect of cord blood eye drops administration on the variation of corneal damage in patients with severe keratopathy'}], 'secondaryOutcomes': [{'measure': 'Change in discomfort', 'timeFrame': 'one week before the start of treatment and thirty days after the end of treatment.', 'description': "Symptomatology assessment with OSDI questionnaire. Quality of life analysis with Health-related SF-12 questionnaire, and SEI-QoL subjects' quality of life scale."}, {'measure': 'Change in quality of life', 'timeFrame': 'one week before the start of treatment and thirty days after the end of treatment.', 'description': 'Change in QOL measured by SF-12 questionnaire'}, {'measure': 'Change in quality of life', 'timeFrame': 'one week before the start of treatment and thirty days after the end of treatment.', 'description': 'Change in QOL measured by SEI-QoL questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The study aim to evaluate the efficacy of cord blood eye drops in the healing of the damaged corneal epithelium.', 'detailedDescription': 'Patients undergoing treatment with EGFR inhibitor for lung cancer might develop corneal damage.\n\nThe study aims to evaluate the healing of corneal epithelium by administering cord blood eye drops for one month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years\n* oncology and advanced cancer patients who have EGFr mutation and who require treatment with antiEGFr drugs\n* signing of informed consent\n\nExclusion Criteria:\n\n* Patients who are unable to store/administer the CSCO independently, or with the help of care-givers.'}, 'identificationModule': {'nctId': 'NCT06830551', 'briefTitle': 'The Effect of Cord Blood Serum Eyes Drops Administer in Patients With Severe Keratopathy Related to EGFR-I Treatment', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Personalized Approach in the Treatment of Patients Affected by Severe Dry Eye Associated With Therapy With EGFR Inhibitors (EGRFR-I) With Growth Factors in Cord Blood Serum (CBS) Eye Drops', 'orgStudyIdInfo': {'id': 'OFTAFONTANA_DED_EGFR-I'}, 'secondaryIdInfos': [{'id': 'F35F22000080001', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eye drops derived from cordonal blood serum', 'description': 'patients who are given eye drops', 'interventionNames': ['Drug: administration cord blood based eye drops, standardized to the deliver BDNF.']}], 'interventions': [{'name': 'administration cord blood based eye drops, standardized to the deliver BDNF.', 'type': 'DRUG', 'description': 'administration cord blood based eye drops customized to deliver epitelio tropic factors, incluiding EGF in EGFR blocked cells', 'armGroupLabels': ['eye drops derived from cordonal blood serum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Fontana, MD', 'role': 'CONTACT', 'email': 'luigi.fontana6@unibo.it', 'phone': '+390512142837'}], 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Luigi Fontana, MD', 'role': 'CONTACT', 'email': 'luigi.fontana6@unibo.it', 'phone': '+390512142837'}], 'overallOfficials': [{'name': 'Luigi Fontana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}