Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

COVID-19

* Patients with active treatment in adjuvant/induction setting,
* Patients with active treatment in metastatic/relapse setting,
* Patients without active treatment (last treatment above 6 months).

Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected

Additional biological samples

marie kroemer, PharmD, PhD

laura mansi, MD, PhD

Marie KROEMER

Laura Mansi, MD PhD

T-cell adaptive immunity is known to be required to sustain a long term immunoglobulin production and a long term memory against several infections. Previous results suggest a lack in the generation of T-cell responses against CoV-N, M and S proteins among cancer patients exposed to SARS-CoV-2 virus highlighting that cancer patients failed to mount a protective T-cell immunity. Given this context, our hypothesis is that COVID-19 vaccine candidates are not immunogenic in some cancer patients. Thus, the monitoring of CD4 and CD8 T-cell responses before and after vaccination might provide information related to the correlation between induction of CD4 T-cells (including helper follicular T-cells) by the vaccine and long-term IgG production (serological index). Additionally, the failure of COVID-19 vaccines in some patients should be monitor carefully in order to provide specific recommendations to avoid COVID-19 infections. The main objective is to assess humoral immune responses following COVID-19 vaccination in a population of cancer patients.

COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2

Study of Humoral and Cellular Immune Responses Following SARS-CoV-2 Vaccination to Predict Immune Responses in Cancer Patients

Centre Hospitalier Universitaire de Besancon

Neoplasms

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Rituximab

Immunoglobulins

In Cohort A, patients will be included either in the group "sustainable response"or in the "short / refractory response" group.

- "sustainable response" group : patient with NHL diffuse large B cells, and persistent complete response for at least 6 months after first-line treatment with Rituximab OR patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstrom's disease in complete response or partial stable response for at least 1 year after first line treatment with Rituximab

"short / refractory response" group : patient with NHL diffuse large B cells, refractory or relapsed in less than 6 months after at least one line of treatment with Rituximab OR patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstrom's disease refractory or relapsed / progression within less than 1 year after at least one line of treatment with Rituximab

For Cohort B patients will be included either in the group "B hematologic therapeutic abstention" or in the group "any blood disease not treated with anti-CD20 antibodies."

"B hematologic therapeutic abstention" group : patient with hematological malignancy whatever the initial expansion stage

"any blood disease not treated with anti-CD20 antibodies" group : patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstorm disease without treatment criteria at diagnosis and with stable disease for at least 6 months

additional biological samples

Cancer-specific splice variants gain significant interest as they generate neo-antigens, that could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature B cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of membrane expression of the spliced isoform.

The investigators group would now determine if it's possible, in patients with lymphoproliferative B, to detect the presence of a specific memory response to delta-CD20 peptides.

If this memory response exists, it will confirm the interest of this antigen as a target for tumor immunotherapy.

* Blood samples will be realized at inclusion and Peripheral Blood Mononuclear Cells (PBMC) will be collected.
* Tumor tissues will be collected if available.

Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B

Symptoms and General Pathology

Neoplasm Metastasis

Neoplasms, Second Primary

Neoplastic Processes

Additional blood samples will be realized at the inclusion of patients. Two optional blood samples could be realized if necessary with at least 3 months apart.

Peripheral Blood Mononuclear Cells (PBMC) will be collected. Tissue tumor will be collected if available.

Christophe Borg, Pr

Marine Jary, Dr

Christophe BORG, Pr

The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.

Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer

time interval between the date of inclusion and the date of first progression or death from any cause.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Additional blood samples will be realized specifically to the study at baseline, at 1 month, at 3 months, and 1 month after surgery (if applicable).

Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected. Tissue tumor is collected during surgery if applicable.

Stefano KIM, Dr

The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.

The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and unpublished data).

Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.

Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

time interval between the date of initiation of treatment and the date of first progression (local, remote \[extent of the disease by RECIST v1.1\] second cancer) or death from any cause.

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Additional blood samples will be realized specifically to the study at baseline, after neoadjuvant chemotherapy (if applicable) and before surgery, 1 month after surgery and 1 month after the last adjuvant chemotherapy cycle.

Peripheral blood mononuclear cell (PBMC), plasma and circulating tumor DNA and RNA will be collected.

Tumor tissue will be collected during surgery.

Bruno HEYD, Pr

François GHIRINGHELLI, Pr

Patrick RAT, Pr

Sylvain MANFREDI, Pr

Ahmet AYAV, Pr

Thierry CONROY, Pr

Ali Reza KIANMANESH, Pr

Patrick DUFOUR, Pr

Philippe BACHELLIER, Pr

This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.

Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable

Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort

DATECAN = Definition for the Assessment of Time-to-event Endpoints in CANcer trials

Cancéropôle Grand-Est

Carcinoma

Anus Neoplasms

Rectal Neoplasms

Anus Diseases

Anal Cancer

Nivolumab

Patients enrolled in OPTIMANAL clinical trial

* Biomonitoring blood sample will be collected: 6 EDTA tubes (6 mL) for PBMC (peripheral blood mononucleated cell), 1 EDTA tube (6 mL) for plasma freezing and 2 EDTA tubes (4 mL) for ctDNA:

  * at baseline,
  * at first tumor assessment (phase 2 in OPTIMANAL study),
  * at second tumor assessment (phase 4 in OPTIMANAL study),
  * at end-point visit.
* A tumor biopsy or archived tumor sample will be mandatory at baseline.

Even if squamous cell carcinoma of the anal canal (SCCA) is a rare disease, its incidence increases worldwide. SCCA is mostly induced by Human papillomavirus (HPV) infections and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of SCCA. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by chemoradiotherapy. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% of disease recurrence rate at 2 years.

The University Hospital of Besançon with the Gercor conducted a prospective clinical trial (Epitopes HPV02 study) including 69 advanced SCCA patients and established a new standard of care based on Docetaxel, Cisplatin and 5-FU (5-FluoroUracil) chemotherapy (DCF). Among 69 patients treated with DCF regimen, 66 patients were evaluable for efficacy end-points. The objective response rate was 86% including 44% of complete response, and 47% of patients were progression-free at 12 months of follow-up from the first cycle of DCF treatment. Thus, the "Epitopes-HPV02" trial has demonstrated a high response rate of the DCF regimen with a higher than expected 12 months progression-free survival rate.These results raised the hypothesis of DCF being an immunogenic chemotherapy and in that demonstrating a possibly new role of taxane-based chemotherapy in SCCA patients. More than 50% of patients in complete remission had a detectable immunological response against peptides derived from HPV oncoproteins (E6 or E7) or from the telomerase antigen (which is transactivated by E6).

LAND study will enroll patients with locally advanced SCCA enrolled in OPTIMANAL clinical trial. OPTIMANAL study will assess the feasibility and efficacy to combine nivolumab to mDCF chemotherapy, followed by the standard chemo-radiotherapy, in high risk locally advanced SCCA patients with T3/T4 N1a or N1b/N1c disease.

LAND study is an exploratory translational study, which will analyze the biological mechanisms of action and our ability to track the immune responses against HPV and telomerase. The investigator group will take advantage of the presence of HPV antigens in most patients to set up a specific immunomonitoring program based on tumor samples and blood-derived lymphocytes to better understand the potential synergisms between immunogenic chemotherapy and anti-PD1 (Programmed Death-1), and to identify valuable biomarkers of treatment efficacy.

* A tumor biopsy or archived tumor sample will be mandatory at baseline. Tumor samples will be collected for HPV, p53 testing and translational research.
* Biomonitoring blood sample will be collected: 6 EDTA (ethylenediaminetetraacetic acid) tubes (6 mL) for PBMC, 1 EDTA tube (6 mL) for plasma freezing and 2 EDTA tubes (4 mL) for circulating tumor DNA (ctDNA):

  * at baseline,
  * at first tumor assessment (phase 2 in OPTIMANAL study),
  * at second tumor assessment (phase 4 in OPTIMANAL study),
  * at end-point visit

Immunomonitoring and Biomarker Research in Patients With Squamous Cell Anal Carcinoma

Immunomonitoring and Biomarker Research Based on Tumor and Blood Samples in Patients With Squamous Cell Anal Carcinoma

Correlation of both peripheral CD4 anti-telomerase immunity and MDSC with progression-free survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
COVID-19-Study of Immune Responses Following Vaccination Against SARS-CoV-2	NCT04836793	Cancer Elderly Healthy Aging	Additional biol...	18 Years -	Centre Hospitalier Universitaire de Besancon
Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B	NCT02844491	Hematological M...	additional biol...	18 Years - 70 Years	Centre Hospitalier Universitaire de Besancon
Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer	NCT02838381	Metastatic Canc...	Additional biol...	18 Years -	Centre Hospitalier Universitaire de Besancon
Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer	NCT02817178	Metastatic Colo...	Additional biol...	18 Years -	Centre Hospitalier Universitaire de Besancon
Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable	NCT02818907	Pancreatic Canc...	Additional biol...	18 Years -	Centre Hospitalier Universitaire de Besancon
Immunomonitoring and Biomarker Research in Patients With Squamous Cell Anal Carcinoma	NCT03942900	Anal Canal Canc...	Additional biol...	18 Years -	Centre Hospitalier Universitaire de Besancon

Spots Global Cancer Trial Database for additional biological samples