Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 1:42 AM
Study NCT ID:
NCT04774133
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2021-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to quantify the variation in lymphocyte subpopulations T, NK, B, Breg and Treg,', 'timeFrame': '12 months', 'description': 'quantitative variation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasm']}, 'descriptionModule': {'briefSummary': 'Radiotherapy has an important role in the treatment of prostate cancer both as curative treatment and postoperative or salvage ones. Several studies demonstrated a significant reduction of lymphocytes during RT but there are only a few studies monitoring these cells in the treatment of prostate cancer. This study will enroll 50 patients with hystologically proven prostate cancer who will undergo to radiotherapy according to Institutional protocols.\n\nThis study aims to evaluate the effect of RT on immuno-regulatory B, NK, T, B and T lymphocyte subpopulations (Breg and Treg) and plasma cells, quantitative / qualitative changes,their correlations with the clinical course of the disease and acute and late toxicity. In parallel, using multicolor panels (12 colors) we will evaluate the expression of inhibitory checkpoints and TGFβ signaling.\n\nThe final objective is to identify new therapeutic targets to be combined with RT.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically documented prostatic cancer\n* Indication to perform radiotherapy treatment\n* Age over 18 years\n* Informed consent\n\nExclusion Criteria:\n\n* Hematological diseases\n* Autoimmune diseases\n* Previous neoplasias\n* Prior chemotherapy or other therapies that may have violated the hematopoietic organs\n* Patient's refusal to undergo periodic blood samples"}, 'identificationModule': {'nctId': 'NCT04774133', 'briefTitle': 'The Immunodynamic Effect of Radiotherapy in Prostate Cancer Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.', 'orgStudyIdInfo': {'id': '1163/18'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pazients will undergo to blood samples at predefined times'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Sanguineti, Head Physician', 'role': 'CONTACT', 'email': 'giuseppe.sanguineti@ifo.gov.it'}], 'facility': 'IRCSS Regina Elena', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Giuseppe Sanguineti', 'role': 'CONTACT', 'email': 'giuseppe.sanguineti@ifo.gov.it', 'phone': '0652666125'}, {'name': 'Paola Franzoso', 'role': 'CONTACT', 'email': 'paola.franzoso@ifo.gov.it', 'phone': '0652666125'}], 'overallOfficials': [{'name': 'Giuseppe Sanguineti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IFO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Paola Nisticò', 'class': 'UNKNOWN'}, {'name': 'Iole Cordone', 'class': 'UNKNOWN'}, {'name': 'Adriana Faiella', 'class': 'UNKNOWN'}, {'name': 'Paola Trono', 'class': 'UNKNOWN'}, {'name': 'Serena Masi', 'class': 'UNKNOWN'}, {'name': 'Roberta Merola', 'class': 'UNKNOWN'}, {'name': 'Anna Antenucci', 'class': 'UNKNOWN'}, {'name': 'Maria Laura Foddai', 'class': 'UNKNOWN'}, {'name': 'Maria Consiglia Ferriero', 'class': 'UNKNOWN'}, {'name': 'Diana Giannarelli', 'class': 'UNKNOWN'}, {'name': 'Paolo Di Ridolfi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radioinduced Modifications of Lymphocyte Subpopulations Involved in Resistence and Escape Mechanisms to Radiation Therapy of Localized Prostate Cancer.', 'investigatorFullName': 'Giuseppe Sanguineti', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}