Participants with newly diagnosed cancer of lung, breast, digestive tract, urinary tract and etc.

Participants without a cancer diagnosis after routine cancer screening tests.

Yong Qin

Jun Wang

Ziyu Li

Xiaohui Wu

This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.

Blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis will be prospectively collected to identify cancer-specific circulating signals through integrative multi-omic analysis. Based on the comprehensive molecular profiling, a machine learning-driven model will be trained and blinded validated independent through a two-stage approach in clinically annotated individuals. Approximately 10327 cancer patients will be enrolled in this study and early-stage cancer patients will be enriched to improve the model sensitivity on distinguishing cancers with favorable prognosis. Approximately 6339 age and sex matched controls will be included in model development, which are volunteers without a cancer diagnosis after routine cancer screening tests.

a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）

PROFOUND Study: Development and Validation of a Multi-cancer Early Detection Model Based on Peripheral Blood Multi-omic Analysis and Machine Learning: a Multicenter, Prospective, Observational, Case-control Study

To develop a questionnaire to evaluate the high-risk factors in the multi-cancer early screening, including lung cancer, gastrointestinal cancer, gynecological cancer, urogenital neoplasms, etc.

The sensitivity, specificity and tissue origin accuracy of multi-omic-based multiple cancers early detection model in in the population with suspected cancer at 95% confidence interval.

To simulate the positive predictive value and negative predictive value of different multi-cancer early detection models（cfDNA methylation-based or multi-omic-based)，based on the sensitivity, specificity and tissue origin accuracy，according to multi cancer prevalence and staging data of individuals aged 40-75 years in China.

To simulate the stage-shift and incremental cost-effective ratio (ICER) benefit when compared to usual care (SOC screening) using Markov model based on MCED test performance

Exploring biomarkers in methylomics and fragmentomics，and constructing multimodal for multi-cancer early detection based on multiomics analysis

The sensitivity, specificity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.

The sensitivity and tissue origin accuracy of cfDNA methylation-based multiple cancers early detection model in detecting stage I to II cancer at 95% confidence interval.

The sensitivity, specificity and tissue origin accuracy of multi-omic-based multiple cancers early detection model in detecting cancer or non-cancer at 95% confidence interval.

The sensitivity and specificity of cfDNA methylation-based or multi-omic-based multiple cancers early detection model in different subgroups of the population (such as age, gender, cancer pathological classification, and clinical stage) at 95% confidence interval.

Peking University People's Hospital

Shanghai Weihe Medical Laboratory Co., Ltd.

Heart and Blood Diseases

All Conditions

Heart Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Home environs-based lifestyle counseling Involves Spanish-speaking community health workers interacting with intervention subjects in home visits and phone calls - 12 contacts overall. The counseling focuses on promoting subject adherence to the Dietary Guidelines for Americans (DGA) and the Physical Activity Guidelines for Americans (PAGA) with special attention devoted to changing the home environment to make it optimally supportive of the lifestyle choices consistent with the DGA and PAGA. Study participants will also be provided 4 group education sessions that will be devoted to improving subject adherence to the DGA and PAGA.

Cancer Early Detection Spanish-speaking health educators will interact with study participants via a home visit and four telephone calls. The focus of the health education will be on practical strategies to detect cancer early to help prevent death from cancer. Cancer sites of interest will be: breast, cervical, skin, colon, prostate and testicular cancers. In addition, study participants will be provided two group education classes that will focus on the basics of the cancer process and why early detection and intervention can be life-saving.

Social learning theory-based behavior modification embedded in a social ecological framework is used to shape both the home environment and the lifestyle choices of the study participants to optimize their adherence to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.

Home environs-based lifestyle counseling

Conventional health education is used to increase study participant knowledge of practical strategies for detecting and treating common cancers early, before cancers have metastasized. Additional instruction is devoted to the biology and physiology of the cancer process. Although some mention will be made of the importance of maintaining a healthy weight for minimizing lifetime risk of certain cancers, most of the focus will be on episodic cancer screening, e.g., mammograms, PAP smears, colonoscopies, etc. for prevention of death from cancer.

Cancer early detection

William J McCarthy, Ph.D.

This family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. The hypothesis being tested is that home environment-focused health behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease. The community health workers will provide most of the health promotion counseling. The promotores will provide up to 16 counseling sessions to a designated adult family member without diabetes. The sessions will focus on improving the home environment in order to reduce television viewing, increase fruit and vegetable intake, decrease intake of refined carbohydrates, prompt more frequent monitoring of body weight and increase daily physical activity. The lifestyle change goals will be tailored to the families' capacity for change and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of daily moderate physical activity.

This is a randomized controlled trial involving non-diabetic residents of East Los Angeles, most of whom are low-income, mostly immigrant Mexican Americans. The family environment-focused health behavior change intervention is being carried out by extensively trained community health workers (promotores) familiar with the community in East Los Angeles. The comparison condition is a more traditional health education approach to teaching residents about practical early cancer detection strategies designed to reduce risk of death from cancer.

The hypothesis being tested is that home environment-focused health behavior change will reduce risk of arterial stiffness, an early-in-life predictor of heart disease. The community health workers will provide most of the health promotion counseling. The promotores will provide up to 16 counseling sessions to a designated adult family member without diabetes. The sessions will focus on improving the home environment in order to reduce television viewing, increase fruit and vegetable intake, decrease intake of refined carbohydrates, prompt more frequent monitoring of body weight and increase daily physical activity. The lifestyle change goals will be tailored to the families' capacity for change and will be consistent with the Dietary Guidelines for Americans, especially the MyPlate.gov messages, the Dietary Approaches to Stop Hypertension (DASH) diet and at least 30 minutes of daily moderate physical activity.

Secondary outcomes include: aerobic fitness, fruit and vegetable intake as assessed by food frequency questionnaire, endothelial function, body mass index, waist circumference, blood pressure, a metabolic syndrome score, and quality of life. Relative to the cancer early detection condition, the lifestyle change intervention is expected to improve fitness, increase fruit and vegetable intake, improve endothelial function, improve BMI, reduce excess waist circumference, improve blood pressure, and improve quality of life.

If results confirm hypotheses, the results will support investing more public health resources into environmental and policy strategies design to make it easier for populations to adhere to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.

Promotora-based Latino Family CVD Risk Reduction

Promotora-based Latino Family CVD Risk Reduction: Remaking the Home Environment

Pulse wave velocity is a measure of arterial stiffness that is sensitive to changes in health-related lifestyle changes.

Augmentation index is another measure of arterial stiffness, also sensitive to changes in health-related lifestyle behaviors.

Glycosylated hemoglobin A1c. Measure of glucose control over several months.

Self-report questions about adherence to MyPlate.gov recommendations. These include questions about daily fruit intake, vegetable intake, replacement of sugary beverages with water, effort to make at least 1/2 of grain intake whole grain, effort to seek out lower sodium options, and daily intake of non-fat or low-fat milk.

Block Food Frequency assessment conducted in Spanish by interview. Information will include estimate of total fruit and vegetable intake over the last 6 months.

Measure of waist circumference, a common predictor of cardiovascular risk

Bruce protocol treadmill test. Estimate the VO2max (maximum aerobic capacity) using Foster's equation.

Metabolic syndrome marker levels. The ATP III criteria for metabolic syndrome markers include:

* sex-specific excess waist circumference (men \> 102 cm, women \>88 cm),
* fasting plasma triglycerides \>= 120 mg/dl,
* fasting plasma HDL(men)\<40 or (women)\<50 mg/dl,
* blood pressure \>=135/85,
* fasting glucose \>=110 mg/dl). Each subject's metabolic syndrome marker level can range between zero and five, with zero representing no metabolic syndrome risk and five representing maximum risk. The a priori expectation is that each marker will be treated as equally important but this study will provide the opportunity to examine this assumption critically.

Plasma lipids to be measured include LDL-cholesterol, HDL-cholesterol and triglycerides. Blood samples will be obtained by venipuncture.

Blood pressure will be assessed in study participants sitting quietly by trained personnel using regularly calibrated sphygmomanometry.

International Physical Activity Questionnaire - short form (IPAQ-short). Questions ask about the number of days in the last 7 days that the participant exercised vigorously or moderately vigorously. Follow-up questions query the participant about the time (minutes \& hours) spent per day in doing vigorous or moderately vigorous physical activity on those days when they exercised.

Body mass index (BMI) obtained by taking the ratio of measured weight (kg) to measured height (m). Weight is obtained using a regularly calibrated balance beam scale. Height is obtained using a stationary stadiometer.

The SF-12 is a well-accepted short form of the well-known SF-36 quality of life instrument.

Questionnaire includes 11 items that query the participant about weight control strategies used in the last year, including: exercise, restricting calories, fasting, diet pills, vomiting / laxative use, joining a gym, joining a commercial weight loss program such as WeightWatchers, meal replacement products, herbal medicines, diet bars, restriction on TV watching.

Flow-mediated dilation is the most widely used non-invasive test for assessing endothelial function, that is, the functional status of the inner lining of the major blood vessels. This technique measures endothelial function by inducing reactive hyperemia (blood volume expansion) via temporary arterial occlusion (blocking blood flow with inflated blood pressure cuff) and measuring the resultant relative increase in blood vessel diameter via ultrasound.

List of 10 self-efficacy items that assess the study participant's confidence that she/he can adhere to various features of the Dietary Approaches to Stop Hypertension (DASH) diet.

Mental health index-5 (MHI-5) consists of 5 questionnaire items designed to assess emotional well-being.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）	NCT06217900	Cancer		40 Years - 74 Years	Shanghai Weihe Medical Laboratory Co., Ltd.
Promotora-based Latino Family CVD Risk Reduction	NCT01714271	Heart Disease Cancer	Home environs-b... Cancer early de...	18 Years -	University of California, Los Angeles
Promotora-based Latino Family CVD Risk Reduction	NCT01714271	Heart Disease Cancer	Home environs-b... Cancer early de...	18 Years -	University of California, Los Angeles

Spots Global Cancer Trial Database for cancer early detection