Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Patients suffering from Peritoneal carcinomatoses from either CRC, gastric cancer or primary peritoneal malignancies

Patients suffering from CRC or gastric cancer without peritoneal carcinomatosis

Jens M Werner, MD

Monika Diehl-Bein

Pompiliu Piso, MD

Matthias Hornung, MD

Longitudinal Study of the Effect of Cytoreductive Surgery and HIPEC in Patients With Peritoneal Carcinomatoses

Cross-sectional and longitudinal analysis of cellular immune responses in the context of disease outcome.

Cross-sectional and longitudinal analysis of the microbiome in the context of disease outcome.

Analysis of renal function with respect of different HIPEC regimens

Identification of clinical surrogate parameters for outcome.

blood samples; stool samples; tumor samples; Peritoneal tissue

Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses

Prospective analysis of disease free after CRS/HIPEC for peritoneal carcinomatosis

Prospective analysis of overall survival after CRS/HIPEC for peritoneal carcinomatosis

Screening for acute renal insufficiency by measuring serum chemistry (serum creatinine (mg/dl) before as well as during the first 7 postoperative days

Screening for acute renal insufficiency by measuring serum chemistry (serum urea (mg/dl) before as well as during the first 7 days postoperative

Screening for acute renal insufficiency by measuring urine output (ml/24h) before as well as during the first 7 postoperative days

Longitudinal analysis of the microbial burden within samples will be quantified with droplet digital polymerase chain reaction. Bacterial 16S ribosomal RNA gene sequences will be amplified, sequenced, and analyzed in comparison to publicly available data obtained from healthy volunteers.

Longitudinal analysis of cellular immune responses in blood and peritoneal tissue by flow cytometry. Measuring frequency of NK cell populations within total lymphocyte population

Prospective analysis of quality of life after CRS/HIPEC for peritoneal carcinomatosis. Questionnaire-WHOQOL-BRE produces a quality of life profile. It is possible to derive four domain scores. There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health. The four domain scores denote an individual's perception of quality of life in each particular domain (Physical health (Score 7-35), Psychological (Score 6-30), Social relationships (Score 3-15), Environment (Score 8-40)). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score transformed to 4-20 or 20-100.

Krankenhaus Barmherzige Brüder, Regensburg

University of Regensburg

Head of Surgery

Infections

Respiratory Tract (Lung and Bronchial) Diseases

COVID-19

All Drugs and Chemicals

Vaccines

vaccined salaried staff group (Distinction between

* Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2
* And employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2

non vaccined salaried staff group wtih positive SARS-CoV-2

27 mL blood sample to study the humoral and the cellular immune response

serology and ELISPOT test

7 mL blood sample to study the humoral response

serology

Special populations are people with a risk to dévelop severe forms of a disease. The immunogenicity and efficacy of vaccines in this population may be different compared of the general population.

For Covid-19, special populations are people with chronic diseases (obesity, diabetes, cancer, etc.) and / or immunocompromised and / or elderly. It is therefore important that the safety of new vaccines as well as their efficacy be evaluated.

Thus, in cancer, most immunosuppressions and immunosuppressive treatments (in particular chemotherapy or certain targeted therapies) risk negatively impacting the effectiveness of the anti-SARS-COV-2 vaccine both for the humoral immune responses (antibodies ) and cellular (T lymphocytes). These patients may develop an insufficient post-vaccination immunity. However, it seems that immunosenescence (ie the aging of the immune system) has little impact on the effectiveness of mRNA vaccines and viral vector vaccines.

The Canserovax study evaluates the impact of anticancer treatments on the quality of the humoral (development of antibodies) and cellular (development of a specific T response) immune response to SARS-CoV-2 in patients treated for cancer after vaccination. It is carried out in patients undergoing treatment and in subjects not suffering from cancer, and not treated for this pathology (vaccinated salaried staff of a french cancer center). The aim is to qualitatively and quantitatively compare the post-vaccination immune responses in these 2 populations.

The main objective of this study is to describe after anti-SARS-CoV-2 vaccination the humoral immune response against the virus (assay of anti-SARS-CoV-2 antibodies to detect the presence and intensity of humoral immune responses) and the cellular response against the virus (specific T response).

Several cohorts are studied:

* Cohort 1 of vaccinated salaried staff (First group : Employees vaccinated with two doses of vaccine (2 Pfizer doses or 2 Astra doses or 1 Pfizer dose + 1 Astra dose) and never infected with SARS-CoV-2) and second group (Employees vaccinated with one dose of Pfizer or Astra vaccine and previously infected with SARS-CoV-2)
* Cohort 2 of unvaccinated salaried staff (controls)
* Cohort 3 of vaccinated cancer patients (metastatic colorectal, metastatic pancreas and metastatic breast cancer)

Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center

Study of Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response Between 1 and 3 Months After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center

rate of specific SARC-Cov-2 IgM and IgG and Human IFN-γ SARS-CoV-2 ELISpot

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses	NCT04108936	Peritoneal Carc...		18 Years - 80 Years	University of Regensburg
Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center	NCT04935528	Cancer	serology and EL... serology	18 Years -	Centre Georges Francois Leclerc
Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses	NCT04108936	Peritoneal Carc...		18 Years - 80 Years	University of Regensburg
Mechanisms of Anti COVID-19 Humoral and Cellular Immune Response After Vaccination in a Sample of Patients and Salaried Staff From a French Anti-cancer Center	NCT04935528	Cancer	serology and EL... serology	18 Years -	Centre Georges Francois Leclerc

Spots Global Cancer Trial Database for cellular immune response