Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasms

Diseases and Abnormalities at or Before Birth

Infections

Rare Diseases

Syndrome

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Lung Neoplasms

Lung Diseases

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Pulmonary Emphysema

Emphysema

Acute Lung Injury

Bronchitis

Bronchitis, Chronic

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Chronic Graft Versus Host Disease

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Subjects who provide informed consent and meet the eligibility criteria will have 50 ml of blood collected and sent to Freenome or Freenome's designee for processing, testing, and storage, and will then complete a standard-of-care screening LDCT.

blood draw

April Allison, BS

Harris Naemi, BS / Joye Choy, BS

Study Coordinator

Chuanbo Xu, PhD

Nasibeh Vatankhah, MD

The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine, standard-of-care screening Low-Dose Computed Tomography (LDCT).

This is a prospective, multi-center, observational study to evaluate the performance of the Freenome Multiomics Blood Test in screening eligible participants for lung cancer.

Enrollment will be open to all eligible participants for screening chest CT scan as part of the Standard of Care (SOC) for lung cancer. Subjects who meet the eligibility criteria for this study and provide informed consent will be enrolled and blood sample collection must be completed within 30 days of signing the informed consent. Optimally, the screening chest CT will be completed on the same day of the study blood collection, however up to 45 days will be allowed after study blood collection to obtain a screening chest CT.

The study will also collect demographic data and relevant clinical data, such as medical history, lifestyle, occupational and environmental exposure(s), family history, and clinical laboratory data. All reports and clinical notes regarding the diagnostic tests and procedures related to lung cancer diagnosis or lung lesion assessment, such as histopathology and bronchoscopy reports, and diagnostic/follow-up images and imaging reports will be collected as part of follow up to the screening chest CT scan.

All enrolled subjects will be followed prospectively from the date of the baseline screening chest CT until a minimum of 24 months, or until a premature study endpoint inclusive of withdrawal of consent or death.

Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome Multiomics Blood Test

Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening

The PROACT LUNG Study: A Prospective, Observational,Clinical Validation Study of the Freenome Multiomics Blood Test for Lung Cancer Screening (FRNM-007)

Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 12-month follow-up period

Clinical performance of the Freenome Blood Test, including sensitivity and specificity, in detecting lung cancer in subjects with positive and negative lung cancer outcomes during a 24-month follow-up period

Freenome Holdings Inc.

Immune System Diseases

Blood and Lymph Conditions

Asthma

Mesothelioma

Mesothelioma, Malignant

Sarcoidosis

Bronchial Diseases

Hypersensitivity

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Pleural Neoplasms

Lymphoproliferative Disorders

Lymphatic Diseases

Hypersensitivity, Delayed

Chronic Disease

Disease Attributes

Communicable Diseases

Respiratory Tract Infections

Malignant Mesothelioma

William Krimsky, M.D.

The purpose of this study is to create a patient registry to collect and analyze information on subjects treated with the CryoSpray Ablation™ System post-510K approval.

The proposed registry is a prospective, multi-center study of patients that are currently undergoing CryoSpray Ablation™. A maximum of 50 investigational sites will participate in this study.

The study population consists of patients who are being treated with the CryoSpray Ablation™ System for thoracic diseases. Enrolled subjects must have a signed consent form for data collection.

CryoSpray Ablation(tm)Thoracic Patient Registry

Reset Medical, Inc.

CSA Medical, Inc.

Plaque, Atherosclerotic

Pathological Conditions, Anatomical

thoracic scan Low dose

BLOOD SAMPLE

FECES SAMPLE

Emilie GARRIDO PRADALIE

Patients treated at the Hôpital Nord de Marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer \> 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations) Interventional study with minimal risks and constraints, with evaluation of lung cancer prevalence; immunological, blood inflammatory and microbiota profile

Determine the maximum clinical, radiological, and biological phenotyping completeness rate following the implementation of a new lung cancer screening care pathway with multidimensional clinical, radiological, and biological phenotyping capabilities

Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE

Assistance Publique Hopitaux De Marseille

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Musculoskeletal Diseases

Digestive System Diseases

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Ear, Nose, and Throat Diseases

Diabetes Mellitus

Anxiety Disorders

Depressive Disorder

Dementia

Kidney Diseases

Alzheimer Disease

Osteoporosis

Thyroid Diseases

Hyperlipoproteinemias

Hyperlipidemias

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Depression

Heart Failure

Stroke

Hypertension

Gastroesophageal Reflux

Ischemia

Arthritis

Irritable Bowel Syndrome

Arthritis, Rheumatoid

Hepatitis A

Hepatitis

Acquired Immunodeficiency Syndrome

HIV Infections

Pain

Hepatitis, Chronic

Musculoskeletal Pain

Ischemic Attack, Transient

Diverticulum

Diverticular Diseases

Vascular Diseases

Gastrointestinal Diseases

Joint Diseases

Brain Diseases

Central Nervous System Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Dyslipidemias

Lipid Metabolism Disorders

Muscular Diseases

Neurologic Manifestations

Brain Ischemia

Cerebrovascular Disorders

Familial Alzheimer Disease

Intervention group (n = 163) Intervention: Participates in DIMAC02 Program

Health Administrative Data Group (n = 1630) Number of matched data controls. Not taking part in intervention.

Integrated Approach For Chronic Diseases (DIMAC02) is an integrated approach for chronic disease prevention and management services that aims to improve and coordinate different regional initiatives in 11 Family Medicine Groups(FMG) related to : Self-management, Case management, Patient-centred care for persons with multimorbidity, Motivational approach, Interprofessional collaboration. DIMAC 02 specific objectives are: 1) To make available, in FMG's, an interdisciplinary educational intervention for prevention and management of chronic diseases for patients with low and high risk for complication. 2) To Increase the flow of communications between FMG and hospital facilities to improve continuity of care.

DIMAC02

Martin Fortin, MD, M.Sc

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 3 other provinces: British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.

A recent systematic review on the prevalence of Multimorbidity (MM) recommended a count of 3+ chronic diseases, with no focus on any single chronic disease in particular. This definition identifies a more vulnerable population with higher needs, lower income or poverty, poorer outcomes and challenging processes of care. It includes people with a wide array of complexity from the uncomplicated course of minimally interacting chronic diseases to the highly complex MM patients. MM is not only important due to the burden on patients, but because it accounts for high utilization. The definition represents a continuum of vulnerability in which there are many opportunities for prevention and management. Despite the high prevalence of MM, most research and health care is still based on a single disease paradigm which may not be appropriate as 45% of primary care patients have MM. A recent Cochrane systematic review on the impact of interventions for patients with MM has identified a paucity of studies internationally with mixed results, thus paving the way for the work of this Team. The most promising intervention, to date, was enhanced teamwork in a multifaceted intervention involving multiple professionals.

Patient-Centred Partnerships between Patients and Providers: The definition of patient-centred partnerships is derived from Canadian policy reports: "collaboration between informed, respected patients and a healthcare team." There is an internationally accepted comprehensive operational definition with four components which will guide many aspects of the proposed research program: first, exploring the patients' diseases and the illness experience; second, understanding the whole person in context; third, finding common ground; and fourth, enhancing the patient-provider relationship. There is empirical evidence for the impact of patient-centred partnerships on better patient outcomes and lower costs. Systematic reviews of interventions indicated promising results for feasible practice-based interventions targeting both providers and patients.

Canadian policy reports defined this second facet of patient-centredness, as "seamless coordination and integration of care." Transitions requiring coordination are a key feature of care for patients with MM. Coordination has been shown to positively impact: symptom relief; social functioning; hospital re-admission and related costs. Papers reviewed by this Team identified the most promising type of intervention to be structured delivery system re-design.

STUDY #2.1 Qualitative Evaluation of the aligned Programs Purpose: The study will: assess how the transformed program performs; distinguish between components of the interventions; and identify contextual factors that may have influenced the content and effectiveness of the intervention. It will also examine the local barriers and facilitators as well as the transitions and coordination of care.

Methods and design: The Team will conduct a qualitative evaluation of the transformed programs to explain how various contexts influence observed effects \[1\] including the context of the health care systems in each province. A recent example of this research approach in Canada is Best et al, 2012 \[2\]. Data will be obtained from interviews and written documents. In-depth interviews will be conducted among the four categories of stakeholders. This will include: a) decision-makers (n = 10); b) primary care physicians (n = 10); c) professionals doing the interventions (n = 10); and a d) purposive sample of patients with multimorbidity (n = 10) and their informal caregivers (n=10) \[51\]. The number of interviews are estimates and will be guided by the saturation of data \[3\].

Data collection: In-depth interviews, lasting 30 to 60 minutes will ensure complete and detailed participation. The data collection will be held during the second year of the transformed program. The interview guides will examine how the context variables influence the effects and the elements that could potentially inform the development of future interventions. All interviews will be audiotaped and transcribed verbatim. Additionally, written documents will be collected (program team meeting summaries, a sample of 10 medical records or research records at each participating site, a checklist describing the fidelity of the intervention, all documents produced specifically for the intervention) to provide an in-depth understanding of the various contexts in which the interventions occurred.

Data analysis: The data will be analyzed using an iterative and interpretative approach \[4\]. The data from all participants will be examined through both independent and team analysis occurring in a concurrent manner to build and develop on the emerging themes. A coding template will be developed and edited as new themes emerge while others are reclassified or discarded. A data management software will be used to organize the coded data and identify exemplar quotes reflecting the central themes. All written documents will undergo a content analysis. The final step of the analysis will be the triangulation of the synthesis of the themes from the stakeholder participants and the content analysis of the documents.\[3-4\] STUDY #2.2: Evaluation of effects of the aligned Programs Setting: The same consenting participating sites as described in study 2.1. The methods presented below are for one setting and will be duplicated in the second setting. Patients are referred to receive the services of these programs by their providers. The intervention the investigators are testing here is the aligned programs. Patients referred to these programs are new patients and have never been exposed to the intervention. In addition to the main reason for referral to the program, the referral form will also include eligibility details for the evaluation, including diagnoses.

Patient sample: Patients recruited for the study will be cognitively intact and literate and aged between 18 and 80 years of age. The upper limit of 80 years is to avoid recruiting patients at risk of being institutionalized or dependent during the follow-up. Patients will present at least three chronic conditions.

Methods and Design: Patients agreeing to participate will complete questionnaires at baseline (T1) collecting the sociodemographic data and baseline measures, which will be used to document equivalence between groups (groups are defined below). Effectiveness of the aligned program will be assessed using three strategies.

1. To measure short-term effects (4 months), a randomized controlled trial (RCT) design with a delayed intervention will be used \[5\]. Eligible patients will be randomized after consent to receive either the intervention within a short period of time (Group A) or 4 months later (Group B); self-reported mailed questionnaires will be completed at baseline (T1) for all patient participants, 4 months after the end of the intervention for group A (T2) and 4 months after baseline for control group B (T2). This will constitute the short-term measure of effectiveness of the intervention. Group B will then receive the intervention.
2. To measure the mid-term effects (one year) on patient-reported outcomes, a before and after study is proposed combining groups A and B together. The patients will complete the same questionnaire 12 months after the end of the intervention (T3).
3. To measure mid-term (T3) and long-term effects (T4 after 2 years) on health services utilization and cost, all patients (groups A and B) will provide consent to give access to their health administrative (HA) data. At baseline, a control Group C will be constituted using anonymized HA data. Patients will be matched for gender, age, region and main three diagnoses. The Team will build algorithms for matching every set of controls. Groups A and B together will be compared to this propensity matched control group C in a before-after study using administrative (HA) data.

Variables and outcome measures: The variables fall into 5 categories: sociodemographic; PC context; main co-variables of interest; primary outcomes; secondary outcomes. Socio-demographic characteristics include gender, age, education, family income, marital status, occupation, housing and number of persons living under the same roof. Context variables refer to type of PC organization in which the intervention occurs (Family Medicine Group). The three main co-variables of interest are the Team's three innovations: self-reported multimorbidity (measured by the Disease Burden Morbidity Assessment \[6\]; patient-centred partnership (Patient Perception of Patient-Centredness Scale \[7-9\]); and Patient centered coordination (the Patient Perceptions of Transitions in care, adapted by the investigators from Coleman \[10\]). The two primary outcome measures are the Health Education Impact Questionnaire (HeiQ) that provides a broad profile of the potential impacts of patient education interventions \[11\] and the level of perceived disease-management self-efficacy using the 6-item Self-Efficacy for Managing Chronic Disease (SEM-CD) \[12\]. Secondary patient perceived outcomes will be the VR-12 as a measure of health status and the "EuroQoL group" instrument called "EQ5D" as a measure of Quality of Life \[13\]. The Kessler psychological distress scale K-6 will measure psychological distress \[14\]. The investigators will also use a questionnaire on health behaviors \[15\]. Finally, HA data will also be used as secondary outcomes to compare health care utilization and cost before and after the intervention. HA data will include emergency department visits, avoidable hospital admissions, readmissions, time to first primary care visit after emergency department visit and continuity of care.

Data analysis: Investigators will first describe participants' baseline characteristics in each group and compare among groups. To evaluate short-term effect, Groups A and B will be compared on T2 scores with an analysis of co-variance (ANCOVA) adjusted for T1 scores \[16\]. To document mid-term effects, a before and after measures analysis of variance will be used to study the evolution of continuous variables collected 3 times \[17\]. Sub-analyses by gender will be performed. Health system costs in intervention and control groups will be evaluated by using amounts paid to providers based on provincial fee schedules and cost-weighted utilization of institutions including hospitals and long-term care. Utilization records obtained from HA data will be multiplied by applicable cost weights \[18\] The methods employed will model the individual patient-level costs incurred in the health system, using methods developed for costing using administrative data\[19\]. Incremental resources in the intervention group will be identified and costed using applicable time/resource inputs and relevant wage rates following guidelines for economic evaluation in health interventions \[20\].

Patient-Centred Innovations for Persons With Multimorbidity - Quebec

Health Education Impact Questionnaire (HeiQ). Score: Reliable improvement

Multimorbidity/Chronic Disease (MM-21): Score: number of Chronic diseases

Health Status (VR-12): Score: Physical Component Summary (PCS) and the Mental Component Summary (MCS)

Psychological Well-being (Kessler 6 Scale).Score: mean

Lifestyle/Health Behaviours Questionnaire. Score: mean

Patient Perception of Transitions of Care. Score: Mean

Self-Efficacy for Managing Chronic Disease Scale (SEM-CD). Score: mean

Patient Perception of Patient-Centredness (PPPC). Score: Mean

Canadian Institutes of Health Research (CIHR)

Western University, Canada

Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean

Université de Sherbrooke

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening	NCT06122077	Lung Cancer Dia...	blood draw	50 Years -	Freenome Holdings Inc.
CryoSpray Ablation(tm)Thoracic Patient Registry	NCT00785239	Lung Cancer Emphysema Chronic Bronchi... COPD Asthma Sarcoidosis Mesothelioma		18 Years -	CSA Medical, Inc.
CryoSpray Ablation(tm)Thoracic Patient Registry	NCT00785239	Lung Cancer Emphysema Chronic Bronchi... COPD Asthma Sarcoidosis Mesothelioma		18 Years -	CSA Medical, Inc.
Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE	NCT05649046	Smoking-related... Atheroma Chronic Bronchi... Non-progressive... Lung Cancer	thoracic scan L... BLOOD SAMPLE FECES SAMPLE	45 Years - 80 Years	Assistance Publique Hopitaux De Marseille
Patient-Centred Innovations for Persons With Multimorbidity - Quebec	NCT02789800	Hypertension Depression Anxiety Musculoskeletal... Arthritis Rheumatoid Arth... Osteoporosis Chronic Obstruc... Asthma Chronic Bronchi... Cardiovascular ... Heart Failure Stroke Transient Ische... Ulcer Gastroesophagea... Irritable Bowel Crohn's Disease Ulcerative Coli... Diverticulosis Chronic Hepatit... Diabetes Thyroid Disorde... Cancer Kidney Disease Urinary Tract P... Dementia Alzheimer's Dis... Hyperlipidemia HIV	DIMAC02	18 Years - 80 Years	Université de Sherbrooke
CryoSpray Ablation(tm)Thoracic Patient Registry	NCT00785239	Lung Cancer Emphysema Chronic Bronchi... COPD Asthma Sarcoidosis Mesothelioma		18 Years -	CSA Medical, Inc.

Spots Global Cancer Trial Database for chronic bronchitis