Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients with loco-regional, NSCLC treated by definitive radiotherapy.

60Gy in 6 weeks, 50Gy in 4 weeks. Each individual fraction should not exceed 2.5Gy.

Definitive Radiotherapy

David Ball

The main aim is to determine, in patients with locoregional, non-small cell lung cancer (NSCLC) treated by definitive radiotherapy, the influence on survival of the volume of primary tumour, as measured from CT imaging, after adjusting for the effect of the current TNM staging system and other known prognostic factors (especially ECOG performance and weight loss).

Patients with locoregional non small cell lung cancer are registered on study after tumour volumes are outlined by a radiologist and prior to the commencement of any treatment.

All patients must have recorded the volume of disease in the primary tumour (and of involved nodes \> 1 cm diameter) as measured from a CT scan performed according to a standard set of conditions.

Following registration patients are treated with Definitive radiotherapy with or without chemotherapy. Follow-up will occur with the collection of a minimum amount of data every 12 months from the date of registration on study.

Quality Assurance procedures will be implemented with each site that participates in the study.

Lung Tumour Volume Database

Tumour Volume as an Independent Prognostic Factor in Patients With Non-Small Cell Lung Cancer - A Protocol for a Prospective Database.

Survival duration defined as the time from date of registration until death from any cause

Peter MacCallum Cancer Centre, Australia

Trans Tasman Radiation Oncology Group

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Kidney Diseases

Adenocarcinoma

Carcinoma, Renal Cell

Urologic Neoplasms

Urologic Diseases

Urogenital Neoplasms

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Coagulants

Angiogenesis Inhibitors

Adjuvants, Immunologic

Platelet Factor 4

Patients having a radical or partial nephrectomy.

Patients treated by RCC-directed targeted therapy

2 blood samples of 10mL + one urine sample

* on pre-operative d-1/d, post-operative d1 and d5(+/-2),
* one month post-operative,
* at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises.

Biological sample

2 blood samples of 10mL + one urine sample

* before starting the therapy
* at first therapeutic evaluation (2 or 3 months depending on the treatment chosen)
* at the end of the study or at the date of disease progression.

Jean-Christophe BERNHARD, Dr

Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.

The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.

Based on a physiopathological rationale, the use of RCC-directed antiangiogenic therapies into clinical practice leads to conclusive results and makes RCC a particularly well-suited tumor type to study factors involved in the angiogenic process. Furthermore the intensive use of targeted therapies in clinical practice raised new questions about their management.

Therefore the identification of new molecular biomarkers is important:

* to improve the precision of prognostic models currently based on clinical, biological or histopathological variables
* to identify high risk patients that could benefit from an adjuvant treatment or a closer postoperative follow-up
* to predict the response to antiangiogenic therapies and therefore identify the drug which is likely to be the most effective within an ever increasing pharmacopeia
* to follow the therapy as precisely as possible, predict or attest the disease progression justifying a therapeutic modification

Low CXCL4, CXCL4L1 and CXCR3 tumor expression levels are associated with bad prognosis factors in RCC. Consequently their interest in RCC is worth being evaluated, in two subgroups : Localized / locally advanced renal cell carcinoma and Metastatic renal cell carcinoma.

Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) will be evaluated by the association of these markers with time to event occurrence.

Localized or locally advanced renal cell carcinoma group:

* local recurrence
* contralateral recurrence
* extra-renal distant recurrence (metastatic progression)
* specific cancer death
* nonspecific cancer death

Metastatic renal cell carcinoma group :

* local recurrence for patients who underwent a nephrectomy
* contralateral reccurence
* metastatic progression
* specific cancer death
* nonspecific cancer death

Predictive value of therapeutic response will be assessed for patients receiving systemic therapy. It will be evaluated by the association of markers of interest with the therapeutic response.

* RECIST criteria: patients showing a complete response or a partial response, will be considered as "responders"
* The progression of the longest diameter of tumor, the proportion of intra-tumor necrosis (Choi criteria) and +/- the perfusion characteristics of tumor if primitive tumor

University Hospital, Bordeaux

Digestive System Diseases

Symptoms and General Pathology

Carcinoma, Hepatocellular

Recurrence

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Disease Attributes

Data study with inclusion of patients and retrospective clinical data collection, combining :

* Proofreading by radiologist of the CT scan performed (within 2 months prior to surgical intervention)
* Proofreading by iBiopsy® of the CT scan performed (within 2 months prior to surgical intervention)
* Proofreading of tumor sample slides by pathologists
* Patients follow-up (imaging, clinical)
* Recurrence-free survival

Non intervention

Maïté LEWIN, Professor

Tumor recurrence, which occurs in 70% of patients with HCC within 5 years after hepatic resection, is a major cause of post-resection-death. This recurrence can be true recurrence (intrahepatic metastases), which occurs sooner than 2 years later, or it can be due to the development of de-novo tumors at least 2 years later. Despite this high rate of tumor recurrence, no anti-recurrence adjuvant therapies are currently recommended.

Imaging phenomics is the systematic, large scale extraction of imaging features for the characterization and classification of disease phenotypes. Combining imaging and tissue phenomics could be a solution to predict HCC recurrence. With the emergence of molecular therapies and immunotherapies, identifying patients with HCC at high risk of post-resection recurrence would help determine additional therapeutic and management strategies in clinical practice.

Hepatocellular carcinoma (HCC) is among the most lethal and prevalent cancers in the human population and it is now the third leading cause of cancer deaths worldwide, with over 500,000 people affected. Because of the high recurrence rate after curative hepatectomy, accurate prognostic assessment in HCC patients are quite important. With the emergence of molecular therapies and immunotherapies, the identification of patients at high or low risk for recurrence after hepatic resection would help determine additional therapeutic and management strategies in clinical practice. Although many immunohistochemical markers have been reported to have a prognostic value for HCC patients, there is no consensus on how these markers could add prognostic value to the clinical parameters.

In the initial step of biomarker discovery, no specific sample size is provided, however to test hypothesis, 100 patients are required.

This first study will potentially be followed by a second similar study promoted by the same investigators to increase the statistical power to improve the classification tool according to the patient's future.

Period covered by the data collection: 2011-2019 / Duration data collection: 1 year.

The primary endpoint will be built using machine learning method to obtain prediction of recurrence within 2 years. The Recurrence Free survival (RFS) within two years will be the reference outcome to evaluate the prognostic of the patients.

The secondary endpoint are following :

- A secondary endpoint which will be built using machine learning method to obtain prediction of recurrence after 2 years.

The Recurrence Free survival (RFS) after two years will be the reference outcome to evaluate the prognostic of the patients.

- A secondary endpoint will be the correlation between biomarker from CT scan and pathological biomarkers As the spectrum of HCC disease is very large, many patients to conduct conclusive validation studies for diagnostic and prognostic relevance need to be obtained.

Overall, each specific-read out endpoint will include a sample size calculation and - if appropriate - a power analysis specific to the objective of this study.

During training, phenotyping system performance assessment will be done to guide the calculation of the sample size for the validation.

Identification of Image Phenotypes to Predict Recurrence After Resection of Hepatocellular Carcinoma

Correlation between biomarker from CT scan and nodule size, nodule differentiation (grade OMS), nodule capsule, macroscopie invasion, microscopic vascular invasion, macrotrabecular sub-type, satellite nodule, staging.

The primary endpoint will be built using machine learning method to obtain prediction of recurrence within 2 years. The Recurrence Free survival (RFS) within two years will be the reference outcome to evaluate the prognostic of the patients.

A secondary endpoint which will be built using machine learning method to obtain prediction of recurrence after 2 years. The Recurrence Free survival (RFS) after two years will be the reference outcome to evaluate the prognostic of the patients.

Median Technologies

Assistance Publique - Hôpitaux de Paris

Nagwa Ahmed, Lecturer

Ahmed Rhoshdi, assistent prof

Pancreatic carcinoma is ranked the 11th most common cancer worldwide. It is a highly lethal malignant tumor. In Egypt, the disease has traditionally been considered rare, but population in the East Nile Delta region exhibits an unusually high rate of young-onset pancreatic carcinoma. Pancreatic ductal adenocarcinoma is by far the most common histologic subtype of pancreatic malignancy. Programmed death ligand-1 (PD-L1) is a type I trans-membrane glycoprotein. It has an important prognostic and predictive value in various neoplasms. To date, few studies have addressed the potential prognostic role of PD-L1 in pancreatic carcinoma, so knowledge about its prognostic value needs further elucidation.

Pancreatic carcinoma is ranked the 11th most common cancer worldwide. It is a highly lethal malignant tumor with 5-year survival rate as low as 9%. It is the seventh leading cause of cancer-related deaths both in men and women worldwide. In Egypt, the disease has traditionally been considered rare, but population in the East Nile Delta region exhibits an unusually high rate of young-onset pancreatic carcinoma.

Pancreatic ductal adenocarcinoma is by far the most common histologic subtype of pancreatic malignancy, accounting for about 90% of all pancreatic malignant neoplasms. Hence, the terms "pancreatic cancer" and "pancreatic ductal adenocarcinoma" are often used synonymously. Most pancreatic adenocarcinomas occur in the head of pancreas; about 60-70%. Tobacco smoking, diabetes mellitus, obesity, alcohol consumption, family history, certain genetic polymorphisms and chronic pancreatitis have been considered as risk factors for pancreatic adenocarcinoma.

Pancreatic adenocarcinoma typically has a very poor prognosis. Although therapeutic strategies have been developed in recent years, the prognosis isn't significantly improved. To date, a group of prognostic factors are identified for clinical management of pancreatic adenocarcinoma. However, these markers are lack of accuracy to predict the outcome and aren't widely adopted. Therefore, it is still important to find out novel prognostic and predictive biomarkers to explore promising fields of research in terms of treatment selection and tailored therapy in pancreatic carcinoma.

Immunotherapy is a rapidly growing field and represents a paradigm shift in the treatment of malignant tumors; it has made clinically significant breakthroughs in the last decade. Targeting immune checkpoints has had immense clinical success resulting in sustained treatment response for a subset of patients with certain malignancies. Currently, many clinical trials seek to assess the efficacy of immunotherapeutic strategies in pancreatic adenocarcinoma.

Programmed death ligand-1 (PD-L1) is a type I trans-membrane glycoprotein. It acts as a ligand for Programmed death-1 (PD1) and has an important prognostic and predictive value in various types of neoplasms. It is overexpressed in several neoplasms such as bronchogenic carcinoma, hepatocellular carcinoma and breast cancer. PD1 and PD-L1 are immune checkpoints and members of cytotoxic T lymphocyte antigen-4 family. They are responsible for immunosuppression and decreased antitumor cytokines. They are expressed by tumor cells to escape immune surveillance. Moreover, PD1/PD-L1 pathway activates the intercellular signals that inhibit apoptosis and enhance survival of tumor cells. PD1 and PD-L1 are targeted in many clinical trials; blockade of the immune checkpoints activated by the PD-1/PD-L1 pathway has demonstrated impressive benefits in various neoplasms such as melanoma and non-small cell lung cancer.

Blockade of PD-L1 is a prevalent strategy of cancer immunotherapy; the use of checkpoint inhibitors to target the PD1/PDL1 pathway results in breakthrough in the immunotherapy field. A number of studies investigated the association of PD-L1 and prognosis of pancreatic carcinoma, with controversial results presented \[8\]. To date, few studies have addressed the potential prognostic role of PD-L1 in pancreatic carcinoma, so knowledge about its prognostic value needs further elucidation.

The aim of this study is to evaluate the expression of PD-L1 in pancreatic ductal adenocarcinoma and to correlate its expression to different studied histopathological parameters to evaluate its prognostic value.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lung Tumour Volume Database	NCT00351598	Non-Small Cell ...	Definitive Radi...	18 Years -	Trans Tasman Radiation Oncology Group
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux
Identification of Image Phenotypes to Predict Recurrence After Resection of Hepatocellular Carcinoma	NCT05235490	CT Scans Prior ...	Non interventio...	18 Years -	Assistance Publique - Hôpitaux de Paris
Immunohistochemical Expression of PD-L1 in Pancreatic Ductal Adenocarcinoma	NCT05228808	Pancreatic Aden...		-	Sohag University
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux
Lung Tumour Volume Database	NCT00351598	Non-Small Cell ...	Definitive Radi...	18 Years -	Trans Tasman Radiation Oncology Group
Immunohistochemical Expression of PD-L1 in Pancreatic Ductal Adenocarcinoma	NCT05228808	Pancreatic Aden...		-	Sohag University
Immunohistochemical Expression of PD-L1 in Pancreatic Ductal Adenocarcinoma	NCT05228808	Pancreatic Aden...		-	Sohag University
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux

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