Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. The 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03724994
Study type Observational [Patient Registry]
Source Lund University
Contact Karin Jirström, Professor
Phone +46 46 2220829
Email karin.jirstrom@med.lu.se
Status Recruiting
Phase
Start date October 30, 2018
Completion date September 1, 2027

See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Recruiting NCT04183478 - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer Phase 2/Phase 3
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study