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2024-09-06
2028-06-30
2028-06-30
100
NCT06649474
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
INTERVENTIONAL
Evaluation, in Humans, of the Correlation Between Hepatotoxicity, Neurotoxicity Induced by Oxaliplatin, and Blood Levels of HMGB1
Oesogastric and pancreatic adenocarcinomas are poor-prognosis cancers. Incidence of pancreatic cancer drastically increases to such an extent that it will become the second cause of cancer's mortality by 2030. A major challenge is to optimize the therapies for localized setting, when oxaliplatin-based chemotherapy is the standard, before and after surgical excision. Because in 50% of cases oxaliplatin triggers a grade 2-3 sinusoidal obstruction syndrome (SOS) which increases post-operative morbidity, decreases histological response to chemotherapy, increases tumor recurrence, and aggravates the risk of chemotherapy-induced peripheral neuropathy (CIPN). There is an urgent need to better understand the biological processes involved in SOS, in order to prevent and treat it without stopping or reducing oxaliplatin administration. The biological link between oxaliplatin and SOS has not been described, but recent murine experiments argue for HMGB1 to be the mediator released after exposure to oxaliplatin and inducing SOS, and thereafter CIPN. To date, no biomarker is established between murine and patient analyses, and the release of HMGB1 after oxaliplatin treatment and its effect on hepatic parenchyma is not described in patients. Investigators hypothesized is that HMGB1 would also been increased in patients after oxaliplatin treatment, and correlated to the development of SOS and CIPN. If confirmed, personalized treatment will be possible to target this pathway. Therefore, investigators propose to dynamically explore this hypothesis in localized oesogastric and pancreatic cancer patients who will be routinely managed by an initial laparoscopy and post-oxaliplatin surgical excision.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-09-05 | N/A | 2024-10-17 |
2024-10-17 | N/A | 2024-10-18 |
2024-10-18 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: comparate the Serum HMGB1 concentrations between patients with grade <2 SOS and those with grade 2,3 | BIOLOGICAL: assess the serum HMGB1 concentrations before and after an oxaliplatin-based chemotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Serum HMGB1 concentrations | Assess Serum HMGB1 concentrations in two groups of patients : with grade 0 or 1 SOS and with grade ≥2 SOS, at two timepoints: before exploratory laparoscopy and before surgical excision to determinate the effect of HMGB1 on SOS development | At exploratory laparoscopy and at the surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| variation of serum HMGBI concentration (ng/ml) | mesurated the serum HMGB1 concentration (ng/ml) at several time of treatment of the patient then comparated these assess the dynamic variation of serum HMGB1 concentrations after oxaliplatin-based chemotherapy in oesogastric and pancreatic cancer patients with grade 0 or 1 SOS and with grade ≥2 SOS | at the exploratory laparoscopy, at the first (Day1) and last cycle (assessed up to 75 days) of chemotherapy before surgery (each cycle=14 days) and at the surgery |
| variation of serum RAGE (receptor of HMGBI) concentration | mesurated the serum RAGE concentration (ng/ml) at several time of treatment of the patient then comparated these assess the dynamic variation of serum HMGB1 concentrations after oxaliplatin-based chemotherapy in oesogastric and pancreatic cancer patients with grade 0 or 1 SOS and with grade ≥2 SOS | at the exploratory laparoscopy, at the first (Day1) and last cycle (assessed up to 75 days) of chemotherapy before surgery (each cycle=14 days) and at the surgery |
| sinusoidal obstruction syndrome (SOS) diagnosis | compare SOS histology diagnosis (absent, mild, moderate, severe) with no invasive biological scores "APRI and FIB4"which use ASAT (U/L), ALAT(U/L), plaquettes (G/L) and the age (years) of the patient | before to began chemotherapy and from 15 to 21 days after the last cycle of chemotherapy before surgery |
| sinusoidal obstruction syndrome (SOS) diagnosis | compare SOS histology diagnosis (absent, mild, moderate, severe)) with splenic's volumetric measured by radiological's assessment | before to began chemotherapy and from 15 to 21 days after the last cycle of chemotherapy before surgery |
| Evaluated the chemotherapy-induced peripheral neuropathy (CIPN) | the CIPN will be evaluate by the investigator who used the CTCAEv5 classification. | at the first (Day1) and last cycle (assessed up to 75 days) of chemotherapy before surgery (each cycle=14 days); at the surgery and at the first cycle (D1) then last cycle (assessed up to 75 days) after surgery |
| Evaluated the chemotherapy-induced peripheral neuropathy (CIPN) | the CIPN will be evaluate by each patient who completed the CIPN20 questionnary | at the first (Day1) and last cycle (assessed up to 75 days) of chemotherapy before surgery (each cycle=14 days); at the surgery and at the first cycle (D1) then last cycle (assessed up to 75 days) after surgery |
| Evaluated the chemotherapy-induced peripheral neuropathy (CIPN) | the CIPN will be evaluate by each patient who completed the visual analog score for pain | at the first (Day1) and last cycle (assessed up to 75 days) of chemotherapy before surgery (each cycle=14 days); at the surgery and at the first cycle (D1) then last cycle (assessed up to 75 days) after surgery |
| Predictive value of HMGB1 for the development of SOS and CIPN | Correlate CIPN, neuropathic pain with SOS, HMGB1, and RAGE measurements | from exploratory laparoscopy to last cycle of chemotherapy after surgery assessed up to 10 month |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Marine JARY, MD Phone Number: +33 4 73 75 05 08 Email: mjary@chu-clermontferrand.fr |
Study Contact Backup Name: Brigitte GILLET Phone Number: Email: bgillet@chu-clermontferrand.fr |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
