Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Primary Central Nervous System Lymphoma

Retrospective study to search mutations associated with Central nervous system lymphoma and study of the prognostic impact (overall survival and progression-free survival) of these mutations.

Retrospective study

Hervé GHESQUIERES, Pr

Pierre SUJOBERT, Dr

Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example).

A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique.

The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.

Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)

Analysis of progression-free survival correlated with genomic data and mutation data

Hospices Civils de Lyon

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country

Non Interventional study

Bernard Asselain, MD, PhD

Dirk Arnold, MD, PhD

Erika Martinelli, MD, PhD

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting.

This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.

This retrospective, multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns. All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between January 1st, 2016 and December 31st, 2018 (both days inclusive) with drugs registered for mCRC in respective country will be eligible to participate. The study will not provide or recommend any treatment or procedure; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices and all eligible patients will be considered for enrollment.

The target countries for patient enrollment will include Germany, France, Italy, United Kingdom, Spain, Belgium, Austria and the Netherlands. Approximately 300 adult patients (≥18 years) from a mix of academic and non-academic sites (up to 65 sites) will be enrolled.

A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

Agent or combination of agents received, Duration of treatment, Maintenance therapy (if any)

Description of the demographic and clinical profile of patients at the time of treatment initiation (for mCRC)

the length of time between initiation of first-line treatment for mCRC and the first documented disease progression

length of time between first-line treatment initiation (for mCRC) and death (due to any cause)

number of complete response (CR) or partial response (PR)

the length of time between initiation of first-line treatment for mCRC and documented disease progression (or start of subsequent Line Of Treatment (LOT), if disease progression is not well documented in patient medical record), treatment discontinuation or switch to another treatment (defined as change from one treatment regimen to another treatment regimen, e.g., change from FOLFOX-based regimen to FOLFIRI or irinotecan-based regimen)

Clinact

Pierre Fabre Medicament

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Syndrome

Body Weight

Weight Loss

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

No subjects will be contacted or recruited. All data will be acquired retrospectively.

Linda A Gilmore, MD

Orhan Oz, MS

PET has an established role in the initial staging of patients with newly diagnosed lung and gastrointestinal tumors.PET avidity is described with both maximum and mean standardized uptake values.Malignant cells have increased activity on PET, defined as the standardized uptake value (SUV), with increased uptake of FDG in tumor due to elevated levels of GLUT receptors, elevated intracellular levels of hexokinase and increased rates of glycolysis. However, there is a subset of patients with lung and gastrointestinal tumors that are not PET avid.These patients may present with clinically and systemically aggressive disease with a declining performance status and/or weight loss.

This study will be a retrospective review of patients in the tumor registry with lung and gastrointestinal tumors, not limited to but including small and non-small cell lung cancers, stomach cancer, small intestinal cancer, colon cancer, rectal cancer, liver and intrahepatic bile duct cancers, gallbladder and extrahepatic bile duct cancers, and pancreatic cancer.

There will be a maximum of 10,000 charts/records that will be reviewed to compile the data. Data to be collected will include patients' name, medical record number, date of birth, race, ethnicity, gender, medical history, medications, vital and performance status, vital signs including weight and body mass index, date of cancer diagnosis, clinical and pathologic stage, pathology, treatment course, prior treatment, location of primary lesion, and smoking history. CT and PET findings to be reviewed include the number of involved lymph nodes, size of primary tumor, average/maximum PET avidity in both the primary tumor and involved lymph nodes.

PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors

The goal of this assessment is to identify patients with lung and gastrointestinal tumors and collect the data on tumor stage location, histology, PET avidity, and weight loss/performance status so that it will be possible to correlate SUV values associated with cachexia by using CTCAE version 4.0 to collect and log AE and SAE related to cachexia.

University of Texas Southwestern Medical Center

Assistant Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Anti-Infective Agents

All Drugs and Chemicals

Dermatologic Agents

Chlorhexidine

Chlorhexidine gluconate

The medical charts are the subjects. The institutional charts will be identified by the use of definitive radiation therapy correlating with an early stage lung cancer diagnosis during the above time frame. The data from these charts will be entered into a password protected excel spreadsheet. The charts will be identified by name, medical record number, date of birth, and social security number. These are all patients treated by all hospitals and clinics affiliated with UTSW and Parkland. At the time of study, some of the patients will have expired but some will be alive and in the regional North Texas area. Thus, given the minimal risk nature of this retrospective chart review, we could not reasonably conduct this research with a full waiver of consent. The NLST external dataset is proved by the NCI, with no identifying characteristics.

Retrospective Study

Jing Wang, MD

Determine whether CT-based multiparametric analytical models may improve prediction of biopsy and treatment outcome in patients undergoing screening CT scan and/or treatment for early stage lung cancer

The hypothesis is that multiparametric models that incorporate complex image information from screening CT scans will improve prediction of the outcome of subsequent lung biopsy, an invasive diagnostic procedure. In this project, we will construct an image feature-based multiparametric prognostic model for biopsy outcome from screening lung CT scans performed at our institution, and then validate it using theNLST imaging and clinical outcomes dataset.

This study involves no treatment or invasive procedures. Investigator will review all charts of patients who were treated for early stage lung cancer with definitive radiation therapy at UTSW or Parkland Memorial hospital, diagnosed with a malignancy from January 1, 2004 to October 31, 2014, to compile demographic, diagnostic, therapeutic, outcome, and toxicity data. Investigator expect that this will include approximately 200 patient charts. This data will be analyzed statistically and used for future directed research. Investigator will also analyze an anonymized dataset of patients from the National Lung Cancer Screening Trial (NLST) provided by the National Cancer Institute (NCI)

Multiparametric Image Analysis and Correlation With Outcomes in Lung Cancer Screening and Early Stage Lung Cancer

Multi Parametric Image Analysis and Correlation With Outcomes in Lung Cancer Screening and Early Stage Lung Cancer

We will review all charts of patients who were treated for early stage lung cancer with definitive radiation therapy at UTSW or Parkland Memorial hospital, diagnosed with a malignancy from January 1, 2004 to October 31, 2014, to compile demographic, diagnostic, therapeutic, outcome, and toxicity data. The data will be subject to standard descriptive, parametric, and nonparametric hypothesis testing with biostatistical analyses. We will also analyze an anonymized dataset of patients from the National Lung Cancer Screening Trial (NLST) provided by the National Cancer Institute (NCI) including screening images and diagnostic outcomes to validate models generated using institutional data.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)	NCT03859544	Central Nervous...	Retrospective s...	18 Years -	Hospices Civils de Lyon
Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)	NCT03859544	Central Nervous...	Retrospective s...	18 Years -	Hospices Civils de Lyon
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)	NCT04317599	BRAF V600E Muta... Metastatic Colo...	Non Interventio...	18 Years -	Pierre Fabre Medicament
PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors	NCT03568019	Cachexia; Cance...	Retrospective s...	18 Years - 99 Years	University of Texas Southwestern Medical Center
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)	NCT04317599	BRAF V600E Muta... Metastatic Colo...	Non Interventio...	18 Years -	Pierre Fabre Medicament
Multiparametric Image Analysis and Correlation With Outcomes in Lung Cancer Screening and Early Stage Lung Cancer	NCT03563976	Lung Cancer	Retrospective S...	18 Years - 99 Years	University of Texas Southwestern Medical Center

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