Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT03724994
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C000627770', 'term': 'folfirinox'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma samples (for circulating tumor DNA) and serum samples (for cytokines) Tumor cytology and/or tumor biopsy for biomarkers and mutations.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'months'}], 'secondaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': '5 years', 'description': 'months'}, {'measure': 'Disease specific survival', 'timeFrame': '5 years', 'description': 'months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chemotherapy', 'adjuvant', 'palliative', 'prognostic', 'predictive', 'immune response', 'biomarkers', 'mutations', 'cytokines', 'immune cell signatures'], 'conditions': ['Periampullary Adenocarcinoma', 'Periampullary Cancer', 'Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '35149544', 'type': 'BACKGROUND', 'citation': 'Petersson A, Andersson N, Hau SO, Eberhard J, Karlsson J, Chattopadhyay S, Valind A, Elebro J, Nodin B, Leandersson K, Gisselsson D, Jirstrom K. Branching Copy-Number Evolution and Parallel Immune Profiles across the Regional Tumor Space of Resected Pancreatic Cancer. Mol Cancer Res. 2022 May 4;20(5):749-761. doi: 10.1158/1541-7786.MCR-21-0986.'}, {'pmid': '37041522', 'type': 'RESULT', 'citation': 'Olsson Hau S, Williamsson C, Andersson B, Eberhard J, Jirstrom K. Sex and gender differences in treatment intention, quality of life and performance status in the first 100 patients with periampullary cancer enrolled in the CHAMP study. BMC Cancer. 2023 Apr 11;23(1):334. doi: 10.1186/s12885-023-10720-w.'}, {'pmid': '37936126', 'type': 'RESULT', 'citation': 'Hau SO, Svensson M, Petersson A, Eberhard J, Jirstrom K. Trajectories of immune-related serum proteins and quality of life in patients with pancreatic and other periampullary cancer: the CHAMP study. BMC Cancer. 2023 Nov 7;23(1):1074. doi: 10.1186/s12885-023-11562-2.'}, {'pmid': '32293352', 'type': 'RESULT', 'citation': 'Hau SO, Petersson A, Nodin B, Karnevi E, Boman K, Williamsson C, Eberhard J, Leandersson K, Gisselsson D, Heby M, Jirstrom K. Chemotherapy, host response and molecular dynamics in periampullary cancer: the CHAMP study. BMC Cancer. 2020 Apr 15;20(1):308. doi: 10.1186/s12885-020-06807-3.'}, {'pmid': '41044171', 'type': 'DERIVED', 'citation': 'Petersson A, Svensson M, Hau SO, Bergstrom R, Lindberg J, Mayrhofer M, Chattopadhyay S, Eberhard J, Heidenblad M, Leandersson K, Gisselsson D, Jirstrom K. Reliable on-treatment prognostication and target identification with a customized assay for circulating tumor DNA in patients with newly diagnosed pancreatic cancer. Sci Rep. 2025 Oct 3;15(1):34481. doi: 10.1038/s41598-025-22369-5.'}]}, 'descriptionModule': {'briefSummary': "The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that started Sept 1 2018. Patients diagnosed with pancreatic or other periampullary adenocarcinoma undergoing adjuvant och palliative chemotherapy are invited to participate. The study will examine the tumors' molecular dynamics and how this may change over time and with treatment. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life. We estimate that 90 patients will be included in the study per year.", 'detailedDescription': 'The CHAMP (Chemotherapy, Host response And Molecular dynamics in Periampullary cancer) study is a prospective, single-arm observational study that will start Sept 1 2018. All patients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö will be invited to participate. The estimated number of recruited patients is 90/year, 75 with pancreatic cancers. Of note tumour origin can seldom be firmly established in non-resectable cases, where only a fine needle aspiration or biopsy specimen is available before initiation of palliative chemotherapy. Main exclusion criteria are: 1. patients having another concomitant life-threatening disease and 2. patients who are unable to receive chemotherapy will be informed about the study by their oncologist and a research nurse and, if they want to participate, will sign an informed consent form.\n\nThe treatment regimen will follow national guidelines, and will not be affected by the study. Clinical and pathological data will be compiled at study entry. Radiological and clinical workup will be performed every three months. Primary endpoint will be overall survival, secondary endpoints will be disease specific survival, time to progression, and quality of life (EORTC-QLQ-PAN26). Serial sampling of blood during chemotherapy treatment will be performed by a dedicated research nurse along with the clinical routine sampling. Plasma and serum samples for analysis of ctDNA and cytokines, respectively, will be will be drawn before chemotherapy start (timepoint 0/T0), and prior to each additional course of chemotherapy (monthly e.g. gemcitabine based regimens; T1-5 or biweekly e.g. combination regimen FOLFIRINOX; T1-11), and after the last course of treatment (T6 or T12). Peripheral blood mononuclear cells (PBMC) will be isolated from buffy coat in plasma vials before start of chemotherapy (T0), before the second or third (T2/T3) (monthly or biweekly, respectively) course of chemotherapy, before the fourth or seventh (T4/T7) course of chemotherapy, and after the last course of treatment. A homepage is under construction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö will be invited to participate.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients diagnosed with a histologically or cytologically confirmed diagnosis of pancreatic or other periampullary adenocarcinoma undergoing adjuvant or palliative chemotherapy treatment in the Department of Oncology, Skåne University Hospital, Malmö.\n\nExclusion Criteria:\n\n1. patients having another concomitant life-threatening disease and\n2. patients who are unable to receive chemotherapy.'}, 'identificationModule': {'nctId': 'NCT03724994', 'acronym': 'CHAMP', 'briefTitle': 'Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Chemotherapy, Host Response and Molecular Dynamics in Periampullary Cancer', 'orgStudyIdInfo': {'id': 'CHAMP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study cohort', 'description': 'All patients with periampullary adenocarcinoma or pancreatic cancer receiving palliative or adjuvant chemotherapy (e.g. Gemcitabine, Folfirinox, etc.) in the Department of Oncology, Skåne University hospital, Malmö and Lund', 'interventionNames': ['Drug: Gemcitabine']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Folfirinox', 'Gemcitabine - nab-paclitaxel', 'Fluorouracil', 'FLOX', '5-FU', '5-Fluorouracil'], 'description': 'Adjuvant or palliative chemotherapy according to national guidelines', 'armGroupLabels': ['Study cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214 28', 'city': 'Malmo', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Department of Oncology, Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Karin Jirström, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Lund University'}, {'name': 'Karin Leandersson, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Lund University'}, {'name': 'Margareta Heby, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lund University'}, {'name': 'Sofie Olsson Hau, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}