Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Neoplasm Metastasis

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

All Drugs and Chemicals

Herbal and Botanical

Immunomodulating Agents

Cola

Blood and surgical specimen sampling the day of surgery

Sampling

Thomas Aparicio, Pr

Jérôme Lambert, Pr

Diane Goéré, Pr

Colorectal cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). Recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. Understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. Recently, the consensus molecular classification of CRC confirmed the importance of the immune response in CRC by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. However, immunotherapies are effective for only a minority of patients with metastatic CRC. Indeed, anti Programmed cell Death 1 (anti-PD-1), -PD-L1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (MSI), which only represents 5% of metastatic CRCs.

Thus, the aim of this study is to better understand the role of the immune system on the development of CRC and its possible modulation to treat or prevent metastatic recurrences.

Blood and surgical specimen sampling the day of surgery (primary tumor and metastases if applicable)

Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers

Etude et Modulation de la réponse Immunitaire Dans Les Cancers COlorectaux Primaires et METastatiques

Characterize effective immunotherapies in colorectal cancers by demonstrating their effectiveness in a co-culture model between cancer cells and autologous T cells.

Evaluation of transcriptomic differences between tissues or cells from the healthy mucosa compared to those from the primary or metastatic tumor: sequencing of mRNA in the two types of mucosa and comparison of mRNA expression profiles between the latter.

Evaluation of proteomic differences between tissues or cells from the healthy mucosa in comparison to those from the primary tumor by:

multiplexed immunodetection in situ in tissues detection and dosage of proteins in culture supernatants (ELISA), in a co-culture model between cancer cells and autologous T cells, with or without modulation of a pathway targeting the T lymphocyte response by immunotherapy.

Evaluation of the TCR repertoire by sequencing, carried out from:

patient blood, DNA from cancerous tissues and healthy mucosa DNA from the co-culture between cancer cells and autologous T cells, with or without modulation of a pathway targeting the T lymphocyte response by immunotherapy

Assistance Publique - Hôpitaux de Paris

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Patients who have undergone an endoscopy within the last three years and have never been diagnosed with Barrett's esophagus.

Patients who have undergone an endoscopy within the last three years and have histologically confirmed Barrett's esophagus. BE segment must be M\>1cm, and has not be treated with endoscopic eradication therapy (focal mucosal resection without subsequent eradication therapy is allowed).

Sample collection

Julian Abrams, MD

Katharine Boyce, RN

Joel H. Rubenstein, MD

Amy Liu

This is a longitudinal cohort study to assess the impact of repeated sampling of an oral microbiome signature for Barrett's esophagus (BE). Potential participants will be identified through chart review of patients who have had an endoscopy in the past three years.

Saliva collection is non-invasive and can be performed in clinical and non-clinical settings. As such, saliva testing is a highly attractive method for diagnosing and/or monitoring disease. The investigators previously showed that the bacterial make-up ("microbiome") of saliva is highly distinct in patients with and without Barrett's esophagus (BE), a precursor to esophageal cancer that normally can only be diagnosed by undergoing an upper endoscopy. While the microbiome of saliva is felt to be relatively stable over time, it is unclear whether a microbiome signature for Barrett's esophagus is reproducible within individuals. Also, repeated testing of saliva may improve the ability to diagnose Barrett's esophagus.

Longitudinal Oral Microbiome Sampling for BE

Repeated Sampling of the Oral Microbiome to Improve Detection of Barrett's Esophagus

Using a classifier developed from 16S rRNA gene sequencing data, the investigators will calculate the area under the receiver operating curve (AUROC) and associated 95% confidence interval for a classifier with three repeated measures per subject.

This will be measured to determine the degree of consistency of a microbiome-based classifier for each individual's salivary microbiome assessments (three total per subject).

University of Michigan

National Cancer Institute (NCI)

Columbia University

Associate Professor of Medicine and Epidemiology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Head and Neck Neoplasms

Mouth Neoplasms

Oropharyngeal Neoplasms

Laryngeal Neoplasms

Hypopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Mouth Diseases

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Antineoplastic Agents

Immune Checkpoint Inhibitors

The study cohort consist of patients with newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinuses or larynx in stage UICC (Union internationale contre le cancer) II-IVB

The control group consists of patients with no current diagnoses of cancer undergoing surgery at the participating medical center

This is an observational study. Consequently, study participation does not alter the therapy of the treated disease. Blood will be drawn from patients at several time points during and after radiotherapy (RT) and therapy with immune checkpoint inhibitor (ICI) for detailed immunomonitoring of the patients. In addition, faeces and sputum of the patients for microbiomic and metabolomic measures will be collected. Whenever possible, adequate tissue samples are taken from the center of the tumor and a biopsy is taken from the edge of the tumor including the adjacent mucosa in the nearby area without affecting the pathological assessment (study group). Blood, faeces and sputum will be taken from patients of the control group prior to surgery. After surgery, only blood will be taken.

Antoniu-Oreste Gostian, PD Dr. med.

Manuel Weber, PD Dr. med.

Markus Hecht, PD Dr. med.

Manuel Weber, PD Dr. med. Dr. med. dent.

Udo Gaipl, Prof. Dr. rer. nat. habil.

Benjamin Frey, PD Dr.-Ing. Dr. habil. med.

The aim of this prospective non-interventional multi-center trial is to study the prognostic value of intratumoral and systemic immune biomarkers in newly diagnosed non-metastatic head and neck cancer. Furthermore, the local immunological processes in the tumor will be correlated with the systemic immune status determined in the peripheral blood to identify prognostic immune signatures. In addition, tumor organoids will be generated ex vivo for functional biological analyses. The main objective is to create a prognostic score determined by clusters based on tumor immunologic criteria.

Except for human papillomavirus(HPV)-associated oropharyngeal cancer, immunological biomarkers do not influence treatment algorithms in locally advanced head and neck cancer. In the meantime, a prognostic significance of tumor infiltrating lymphocytes has been recognized. However, these biomarkers do not influence clinical decisions. This may be due to previous focus on the entire group of heterogeneous squamous cell carcinomas in the head and neck region, while the tumor localization has been neglected. In addition, the isolated observation of singular immune cell populations may not be sufficient with regard to the complex interactions of the tumor with the local and systemic immune system, e.g. the presence of regulatory T cells (FoxP3+) in immunologically highly active tumors ("inflamed" or "hot") improves the prognosis, whereas the prognosis is worsened in immunologically less active tumors ("immune desert").The immune checkpoint molecule programmed death-ligand 1 (PD-L1) is currently used as a single predictive marker for immunotherapy with PD(L)-1 inhibitors. Certainly, combined prospective analyses of immune cells and immune checkpoint molecules in large patient cohorts are scarce so far. Of note, the prognostic relevance of immune cells and immunologically active substances in the peripheral blood serving as makers for immunotherapies has already been described. Yet prognostic and predictive markers in the peripheral blood have rarely been studied or linked to the local tumor immune status. However, analyses of single biomarkers of local and systemic immune responses and different immune cell populations can be expected to gain prognostic precision through cluster formation and allow grouping of head and neck tumors according to immunobiological criteria rather than anatomic localization. Therefore, the investigators expect to be able to identify an immunobiological biomarker signature for head and neck tumors that will contribute to the development of future individualized treatment approaches leading to precision head and neck oncology.

Immune Biomarker Study for Head and Neck Cancer

Based on the intrinsic immunological biology of the tumors, different immune cells and tumor cell markers will characterize immunological groups using cluster analysis.

Immune matrix of patients assessed by LIPS (liquid immune profile-based signature) (acc. Zhou et al. JITC 2021) and Tumour Associated Lymphocytes (TAL).

The distribution of immune cells and messenger substances in the blood will be examined by means of immunophenotyping in order to add the systemic immune cell composition.

Flow cytometric assessment of the amount of circulating immune cell-distribution per milliliter whole blood according to the LIPS (liquid immune profile-based signature) technique (Zhou et al. JITC 2021).

Electrochemiluminescent MULTI-ARRAY measurement of concentration (pg/ml whole blood) cytokines/chemoattractant cytokines in the serum/plasma of the patients according to the LIPS (liquid immune profile-based signature) technique (Zhou et al. JITC 2021).

Genetic profiling (Whole exome sequencing, RNASeq, ddPCR, realtimePCR) of transcribed genes in blood lymphocytes.

Massspectometric untargeted metabolomic of patients serum/plasma to assess the change of metabolites (pg/ml whole blood) from baseline to end of radiotherapy.

16S rRNA deep sequencing of microbiome in salvia, tumour and stool samples to assess the presence and relative distribution of microbiotes (Operational taxonomic units \[OTUs\]).

University Hospital Erlangen

University Hospital Regensburg

University Hospital Augsburg

University of Erlangen-Nürnberg Medical School

Salivary Gland Neoplasms

Salivary Gland Diseases

Initial diagnosis of primary salivary gland carcinoma in the head and neck region

Initial diagnosis of a benign salivary gland tumor in the head and neck region

Healthy control group. Functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty) without salivary gland tumor.

Evaluation of immune characteristics by using patient's stool, saliva and blood samples.

Studiensekretariat

Translation Radiobiology

Sarina Mueller, PD

Marlen Haderlein, PD

Benjamin Frey, PD

Aims of this study are analyses of tumor metabolome, tumor transcriptome and tumor proteome as well as of the immune infiltration, separated by histological entity. These data will subsequently be compared with the with the detailed immune status determined in the patient's peripheral blood and saliva using machine learning techniques, among others, to create a biomarker cluster for salivary gland tumors. These can be used in clinical routine.

In addition, the investigators would like to study a subset of patients from freshly resected tumor organoids from freshly resected tumor tissue according to already established methods in order to mechanistic investigations of prognostic parameters.

In this study, the prognostic value of local immunological tumor-dependent cell populations will be prospectively investigated and correlated with immunological changes in the blood. Not only single immune cell populations but also the immune score of multiple immune cells or immune cell subsets will be investigated. In addition, the systemic immune status of patients in peripheral blood will be studied longitudinally. Furthermore, the analysis of cytokines and chemokines as well as mRNA and ctDNA in the peripheral blood is blood and the determination of transcription processes in immune cells, especially to extend the especially to extend the prognostic immune signature.

Immune Biomarker Study for Salivary Gland Carcinoma

Different immune cells and tumor cell markers will characterize immunological groups using cluster analysis. Immune matrix of patients assessed by liquid immune profile-based signature (LIPS) (acc. Zhou et al. Journal for ImmunoTherapy of Cancer (JITC), 2021) and Tumour Associated Lymphocytes (TAL).

The distribution of immune cells and messenger substances in the blood will be examined by means of immunophenotyping in order to add the systemic immune cell composition.

Flow cytometric assessment of the amount of circulating immune cell-distribution per milliliter whole blood according to the LIPS technique (Zhou et al. JITC 2021).

Electrochemiluminescent MULTI-ARRAY measurement of concentration (pg/ml whole blood) cytokines/chemoattractant cytokines in the serum/plasma of the patients according to the LIPS technique (Zhou et al. JITC 2021).

Mass-spectrometric untargeted metabolomic of patients serum/plasma to assess the change of metabolites (pg/ml whole blood) from baseline to end of radiotherapy.

16S rRNA deep sequencing of microbiome in salvia, tumour and stool samples to assess the presence and relative distribution of microbiotes (Operational taxonomic units (OTUs)).

Nervous System Diseases

Glioblastoma

Glioma

Brain Neoplasms

Neoplastic Cells, Circulating

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Neuroepithelioma

Glioblastomas, the most frequent malignant brain tumor in adults, are widespread in the brain, despite their discrete appearance on computed tomography (CT) or magnetic resonance imaging (MRI). While this tumor tends to spread widely in the brain, unlike other tumors of the body, it rarely metastasizes, or spreads, to other organs. Approximately 10 percent of patients with glioblastoma develop metastatic disease after radiation or brain surgery. In the absence of radiation or brain surgery, few patients have developed disease spread outside the brain.

During surgery to remove tumors of other organs of the body, such as the lung, prostate, kidney, or ovary, cells from these tumors are routinely found in the bloodstream. These cells are believed to be the reason for the spread of these tumors. In the case of malignant brain tumors, this process of glioma (tumor) cells shedding into circulation has not yet been investigated.

This study will determine whether glioma cells can be detected in the bloodstream of patients undergoing surgery. If glioma cells are absent, it may mean they are unable to penetrate the blood-brain barrier. If they are present, they presumably can penetrate into blood vessels but they may be recognized and eliminated by the immune system, or they may escape detection yet not be able to take hold in the new microenvironment. The results of the study will add to the knowledge of the biology of these highly malignant tumors.

Study participants will be admitted to the hospital for 8 to 10 days. They will undergo a complete physical and neurological exam and blood and urine tests. An electrocardiogram will be performed, and x-rays may be taken. On the morning of surgery, the patient will receive sedation intravenously. A tiny plastic tube called a catheter will be introduced into a vein in the groin through needles. The catheter will be passed through to the jugular bulb, right above the jugular vein, on the same side as the tumor. The patient will then be taken to the operating room for surgery. During surgery, not more than one quarter of a unit of blood will be removed through the catheter. The catheter will be removed before the patient enters the intensive care unit. Another MRI will be taken after surgery.

The study will enroll participants for 2 years. Patients will be followed at 3 months and 6 months after the surgery to make sure the postoperative period is uneventful.

Glioblastomas are the most frequent malignant brain tumor in adults and are widespread in the brain despite their discrete appearance on CT or MRI. While locally aggressive, metastasis of glioblastoma to extracranial organs is considered rare. Approximately 10% of patients with glioblastoma develop metastatic disease after radiation or craniotomy. Few patients have developed extracranial metastatic disease in the absence of surgical resection or radiation. Unlike tumors of other organs such as lung, colon and prostate, the presence of glioma cells in the circulation of patients undergoing surgical resection has not been established. If found absent, glioma cells may be unable to intravasate through the blood brain barrier. If present, these tumor cells presumably can intravasate but may be recognized and eliminated by an immunological process, or they may escape detection yet not be able to take hold in the new microenvironment. The information provided will add to the knowledge of the biology of these highly malignant tumors.

Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor

Detection of Glioblastoma or Anaplastic Astrocytoma Cells in the Circulation During Surgical Resection

National Institute of Neurological Disorders and Stroke (NINDS)

Rectal Diseases

Central Nervous System Depressants

Anesthetics

After inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples.

The samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern:

* Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal
* Peritoneal liquid
* none tumoral peritoneum
* Portal blood
* Peripheral blood
* Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum.

In the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator.

Diane GOERE, MD

Fanny JAULIN, MD

To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers

Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer

After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers	NCT06435689	Colon Cancer Peritoneal Carc...	Sampling	18 Years -	Assistance Publique - Hôpitaux de Paris
Longitudinal Oral Microbiome Sampling for BE	NCT05133102	Barrett Esophag...	Sample collecti...	18 Years -	Columbia University
Immune Biomarker Study for Head and Neck Cancer	NCT05375266	Head and Neck C... Oral Cavity Can... Oropharyngeal C... Hypopharyngeal ... Laryngeal Cance...	Sampling	18 Years -	University of Erlangen-Nürnberg Medical School
Immune Biomarker Study for Salivary Gland Carcinoma	NCT06047236	Salivary Gland ... Benign Salivary...	Sampling	18 Years -	University of Erlangen-Nürnberg Medical School
Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor	NCT00001148	Astrocytoma Glioblastoma Glioma		-	National Institutes of Health Clinical Center (CC)
Immune Biomarker Study for Salivary Gland Carcinoma	NCT06047236	Salivary Gland ... Benign Salivary...	Sampling	18 Years -	University of Erlangen-Nürnberg Medical School
Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers	NCT06435689	Colon Cancer Peritoneal Carc...	Sampling	18 Years -	Assistance Publique - Hôpitaux de Paris
Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer	NCT03613194	Colorectal Canc...	Sampling	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris

Spots Global Cancer Trial Database for sampling

Every month we try and update this database with for sampling cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sampling

Every month we try and update this database with for sampling cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sampling cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.