Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-01-26 @ 11:41 PM
Study NCT ID:
NCT04200118
Status:
UNKNOWN
Last Update Posted:
2019-12-16
First Post:
2019-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013736', 'term': 'Testicular Neoplasms'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2019-12-04', 'studyFirstSubmitQcDate': '2019-12-13', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epigenetic profile of the patient', 'timeFrame': '3 months', 'description': 'The epigenetic analysis will be performed in the laboratories of the company "Sequentia Biotech". The treatment of denatured DNA with sodium bisulfite will be carried out, causing the demining of the cytosine not methylated, preserving the integrity of the Metilcitosines. After DNA sequencing, treated with bisulfite, the methylation state can be inferred directly from the readings aligned against a reference genome: an unmodified cytosine will indicate the existence of methylation in that position, while A thymine (result of PCR amplification after demining) will mean the existence of a non-methylated cytosine. The methylation values will be calculated with the MethylDackel software and the statistical analysis with R package bsseq.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sperm DNA fragmentation', 'Sperm epigenetics', 'Testicular cancer'], 'conditions': ['Male Infertility', 'Cancer', 'Epigenetic Disorder']}, 'descriptionModule': {'briefSummary': 'The prognosis in cancer patients has improved over the years. Survivor rates have increased significantly, and paternity has become an important concern in more than 50% of young male survivors. Sperm cryopreservation before cancer treatment is highly recommendable in these patients, as a strategy to preserve their fertility due to is not possible to predict how the chemo or radiotherapy treatment will affect the spermatogenesis.\n\nThe objective of this study is to evaluate if sperm after an antineoplastic treatment can be safely used. To determine the possible effects of oncological treatments in the spermatogenesis, three parameters will be analyzed, aneuploidy frequencies, DNA fragmentation in single and double-strand breaks and methylation levels to determine epigenetic changes before and after the therapy.\n\nIf cancer treatment affect sperm genetic integrity, it would have a clinical impact in the offspring of these patients. Identify the different side effects of antineoplastic treatments in DNA sperm will provide a clinical improvement in order to select the best sperm sample in an IVF treatment and it will facilitate genetic counseling'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sperm samples before treatment will be used as a control', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with previous history of cancer Patients with several sperm samples cryopreserved to be able to thaw a part without damaging their future options, in case they need them.\n\nPatients treated with chemotherapy and/or radiotherapy Patients have finished their oncological treatment. Patints recovered spermatogenesis after the oncological treatment to be able to obtain a sperm sample.\n\nExclusion Criteria:\n\nPatients with only one sperm sample cryopreserved Patients that are not be able to obtain a fresh sample post treatment Patients with less than 3 million sperm per milliliter'}, 'identificationModule': {'nctId': 'NCT04200118', 'briefTitle': 'Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment', 'organization': {'class': 'OTHER', 'fullName': 'IVI Barcelona'}, 'officialTitle': 'Epigenetic and Genetic Effects in Cancer Patients: Analysis Pre and After Treatment', 'orgStudyIdInfo': {'id': '1901-BCN-011-MQ'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'non intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08017', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marga Esbert, PhD', 'role': 'CONTACT'}], 'facility': 'Ivi Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08017', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Evelin L Molina', 'role': 'CONTACT', 'email': 'evelin.lara@ivi.es', 'phone': '935 316 301'}, {'name': 'Agustín B Boluda', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Evelin L Molina', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana Belén C Balazote', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Verónica G Martínez', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IVI Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Mariona Quera, MSc', 'role': 'CONTACT', 'email': 'mariona.quera@ivirma.com', 'phone': '34-932063000'}, {'name': 'Marga Esbert, PhD', 'role': 'CONTACT', 'email': 'marga.esbert@ivirma.com', 'phone': '34-932063000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}