Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Lung Neoplasms

Colorectal Neoplasms

Stomach Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Stomach Diseases

Stomach Cancer

Le-Son Tran

Thi Van Phan

Trang Dao, Dr

This is a multi-centre, prospective cohort study, aiming to evaluate a blood test in early detection of the four common cancers, based on the investigation of the circulating tumour DNA (ctDNA).

Primary objective: To evaluate the performance characteristics of the blood ctDNA test in early detecting cancers.

Secondary objectives:

* To evaluate the performance characteristics of the test in determining the origin of tumour, as compared to the findings of the imaging diagnostic tests.
* To determine the risk of cancers development in the high-risk population, as compared to that in the moderate-risk group.

This is a multi-centre, prospective cohort study recruiting participants aged 40 or above, who present at the Outpatient Clinic of the study hospitals either for periodically follow-up visits for their chronic conditions, or for annually health check-up. The study will be conducted at the Medical Genetic Institute, in collaboration with the University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam and other collaborating hospitals.

The potential participants, who satisfy all inclusion/exclusion criteria will be recruited into this study. These potential participants should not have history of cancer before being enrolled in the study.

At enrolment, each participant will answer to a pre-designed questionnaire to provide demographic information, past major medical history and clinical warning signs of cancers, and then provide 10mL of blood for analysing the circulating tumour DNA (ctDNA).

Each participant will get either ctDNA detected or ctDNA not detected.

For those having ctDNA detected in their blood, they will then undergo the screening and diagnostic tests for cancers based on the prediction of tumour origin provided in the test findings report. If the cancers lab-confirmed, patients will then be followed up and managed for their disease according to the guidelines of the Vietnam Ministry of Health and/or the international guidelines on cancers. At 12 months (+/- 1 week) following the enrolment, these patients will be contacted to collect information about their health, in general and their cancer status, in particular.

For those having ctDNA detected in their blood but the present of a mass inside participants' body could not be detected using the imaging diagnostic tests; and for those, who don't have ctDNA presenting in blood, phone calls will be made at 6 months (+/- 1 week) and 12 months (+/- 1 week) following the enrolment to collect information related to participants' health status as well as cancer progress (if possible).

The enrolment is anticipated to last for approximately 6 months.

Samples collected from the participants will be processed and analysed the ctDNA to detect cancer in the early stages and to predict the origin of the tumor. The residual blood of this test will be stored in -80 degree of Celcius for further testing to:- (i) screen or diagnose cancers; (ii) determine the hosts' genetic factors associated with the risks of cancers.

Early Detection of Five Common Cancers Using the ctDNA Analysing Test

Assessment of a Novel Blood Test in Early Detection of the Five Common Cancers Based on the Investigation of the Circulating Tumour DNA

Anonymised data of this study may be requested for publication by journals. Sharing anonymised data with future similar/suitable studies will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organisation than authorized in the study.

Medical University of Ho Chi Minh City

Hanoi Medical University

Hanoi Oncology Hospital

Hue Central Hospital

Da Nang Oncology Hospital

Thong Nhat Dong Nai General Hospital

Dong Nai General Hospital

Van Hanh General Hospital

Can Tho Oncology Hospital

Medic Medical Center

Le Van Thinh Hospital

People's Hospital 115

Xuyen A Hospital

Medical Genetics Institute

Gene Solutions

Participants in this group will receive the intervention. They will receive a Fitbit activity tracker, and will also receive support and goal setting with a view to improving their daily physical activity.

A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.

Intervention

Ciaran Haberlin, BSc(Physiotherapy)

Participants will take part in a 12 week intervention, with at least one follow up at 24 +/- 2 weeks. Each participant will be provided with support, motivation and professional guidance about improving physical activity (PA) levels and will be given a commercially available PA tracker. The PA tracker will also include a smartphone or web-based application, where participants can upload their exercise performed each day, and keep up to date with their goals using their smartphone or by logging on to their computer. The aim of the study is to find out how useful and effective technology with support from a healthcare professional is in helping cancer survivors to become more physically active.

This study will measure objective PA levels of the participants at the start of the study and at the end. The acceptability of using this intervention to promote PA in cancer survivors will also be investigated.

The overall aim is to determine the feasibility of a specific PA intervention, combining technology and professional input, in the cancer survivor population.

Study Design: A single arm feasibility trial of a PA intervention using technology and behavioural change theories as tools to achieve increased PA. Participants in the study will receive 12 weeks of the intervention. Outcomes will be measured at baseline, 12 weeks and 24 weeks (+/- 2 weeks) post baseline.

Patient recruitment: Participants will be recruited from those attending the St. James' Hospital oncology and haematology services. Study personnel will provide further information to these patients and assess them for eligibility. Informed consent will be gained from each participant.

Sample size: Proposed sample size is 60 (based on Sim and Lewis, 2012 recommendations) and allowing for 20% drop-out.

Intervention: This study will use the commercially available 'Fitbit' wearable technology with its paired smartphone application. PA goals will be prescribed by a qualified, chartered physiotherapist using the American Cancer Society (ACS) guidelines (Doyle et al 2006). Participants will use the Fitbit and its paired application for 12 weeks. The Fitbit device is a tool for motivation and monitoring of PA behaviours in this intervention.

This study will also use evidence-based psychological behavioural change theory. Behavioural change techniques include 'self-monitoring of behaviour', 'goal-setting', 'feedback on behaviour' and 'information about health consequences'.

Procedures: This study includes time-points at baseline, 12 weeks (Intervention end) and 24 weeks post baseline (+/- 2 weeks (Follow-up).

Pre-intervention:Consent and PA measurement

* Consent: Study personnel meets potential participants at their outpatient appointment. The agreement of the patient's consultant to exercise has been obtained before the patient information leaflet (PIL) is provided. The researcher explains the study and gives the potential participant a consent form and a patient information leaflet and a verbal explanation of the study.
* Initial PA measurement: Participants who consent are given an Actigraph PA monitor which they will be instructed to wear for 7 days to measure their baseline physical activity levels. Participants who wish to consider the study can take the PIL home, post it back, and receive the Actigraph by post.

Baseline Session:

Participants attend

* 1) An educational session, delivered by the lead researcher, a chartered physiotherapist. This is a group information session on PA following cancer treatment.
* 2) Educational session to introduce the technological component to the participants and instruct them in use and upload of Fitbit data to allow monitoring by researcher(s).
* 3) Measurement of height, weight, BMI and body composition and 6 minute walk test During intervention. (week 1-12)
* Participants wear Fitbit and upload data for self-monitoring and monitoring by chartered physiotherapist researcher.
* Participants receive scheduled structured telephone calls, giving them feedback on their achievement of goals and reminders about uploading data as follows; 2 calls each week till week 4, 1 call a week between week 4 and 8 and 2 calls, 2 weeks apart between week 8 and week 12.

After intervention ends (12 weeks):

* Measurement of height, weight, BMI and body composition and 6 minute walk test
* Participants wear Actigraph x 7 days

  12 weeks after end of intervention:
* Measurement of height, weight, BMI and body composition and 6 minute walk test
* Participants wear Actigraph x 7 days

The IMPETUS Cancer Trial. A Technology Delivered Physical Activity Intervention in Cancer

Investigating the Feasibility and Acceptability of a Technology Delivered Physical Activity (PA) Intervention in Cancer: The IMPETUS Cancer Trial. (IMproving Physical Activity and Exercise With Technology Use in Cancer Survivors)

Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.

The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.

Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes

Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed

The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention

The qualitative outcome in this feasibility study will invite participants' to provide feedback on the intervention's likelihood of being successful. Satisfaction with the technological intervention will be measured using a questionnaire given to participants at study end (12 weeks).

This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in percentage body fat.

A modified version of the Godin Leisure Time Exercise Questionnaire will be used.

The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.

This will be measured using the 6MWT (Six minute walk test).

This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg/m\^2.

This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.

This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.

The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.

University of Dublin, Trinity College

PhD Candidate, Chartered Physiotherapist

Symptoms and General Pathology

Weight Loss

Body Weight

Body Weight Changes

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Bevacizumab

Irinotecan

Cetuximab

Fluorouracil

Oxaliplatin

Panitumumab

stage IV colorectal cancer on first line systemic treatment are observed for the trend of weight change and treatment outcomes

systemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab.

first line systemic treatment for colorectal cancer

Shing Fung Lee, MBBS, M Sc

King Fung Tsang, M Sc

Colorectal cancer (CRC) is a significant and growing health burden in Hong Kong. According to data from Hong Kong Cancer Registry, CRC ranked the first in incidence and the second in mortality, with around 5,000 new cases diagnosed and more than 2,000 cancer-related mortality in 2014. The investigators aim to evaluate the association between serial weight change during first line treatment and outcomes in patients with metastatic CRC.

Studies have suggested that exposure to a greater number of chemotherapeutic agents is associated with better survival in metastatic colorectal cancer.

Multiple factors might affect body weight during treatment. Cancer-related symptoms can impair quality of life and appetite. Cachexia syndrome affects around 50% of colon cancer patients and is characterized by cancer-induced catabolism with involuntary weight loss (fat and muscle), patients have increased lipolysis and change in skeletal muscle metabolism, including increased energy expenditure at rest and protein degradation, and decreased protein synthesis. Besides these disease factors, treatment related side effects are common causes of weight loss, such as inability to ingest or digest food effectively due to nausea, vomiting, and malaise. Based on these factors and the hypotheses between tumour control and weight gain, monitoring the serial weight change can have practical value.

Change in Body Weight During Treatment of Advanced Colorectal Cancer

Clinical Significance of Change in Body Weight During Treatment of Advanced Colorectal Cancer Patients - A Pilot Study

Survival time from start of anti-cancer treatment until disease progression, or death from disease, or loss of follow-up

Survival time from start of anti-cancer treatment until death from any cause, or loss of follow-up

Chemotherapy dose change (in percentage change)

Chemotherapy dose interruption (in percentage change)

Tuen Mun Hospital

Resident Specialist

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Herbal and Botanical

Soy Bean

This is a prospective cohort study of 96,000 members of the Seventh-day Adventists Church in the United States and Canada age 30 and older at the time of enrollment who are proficient in English language.

Gary E Fraser, MD,PhD

The Adventist Health Study-2 is a long-term study, exploring the links between lifestyle, diet, and disease outcomes among Seventh-day Adventists. More than 96,000 church members from the U.S. and Canada are participating in the current study, AHS-2, conducted by researchers at the Loma Linda University School of Public Health.

The Adventist Health Study-2 (AHS-2) is a large national cohort of 96,000 Seventh-day Adventists in the U.S. and Canada. The study is searching for associations between diet and risk of common and medium frequency cancers (breast, prostate, colorectal, lung, uterus, pancreas, melanoma of skin). This cohort is unusual in that about half are vegetarian, many eat soy at Asian levels, and many have very low or absent dairy intake while others eat normal amounts of dairy. Thus observations on these people, many of whom have contrasting dietary habits, may provide insights about diet and cancer, so supporting dietary changes that could be readily adopted by many.

Buffy coat samples from a sample of the cohort (\~2500) are stored from which DNA material may be extracted when a study requires such data. Other stored bio-specimens from a sample of the cohort include adipose tissue, urine, blood, sputum, stool.

Plant-based Diets and Risk of Cancer in the Adventist Health Study-2

Cancer Epidemiology in Seventh-day Adventists

Researchers must write a proposal describing how the data will be used and submit it to the Adventist Health Study data sharing committee for approval.

Incident cases of colorectal cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.

Incident cases of breast cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.

Incident cases of prostate cancer as found by linkage with state cancer registries will allow calculation of hazard ratios comparing extreme quintiles of dietary intakes. The focus is on meats, soy, and dairy intakes.

National Cancer Institute (NCI)

World Cancer Research Fund International

Ardmore Institute of Health

Loma Linda University

Nervous System Diseases

Gland and Hormone Related Diseases

Neuralgia

Pain

Ovarian Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

This is an attention control group with regular contact by study staff.

Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.

Intervention is for 12 weeks 3 times weekly with training on site.

Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.

aerobic exercise intervention

weekly contact by study staff with survivorship information offered not related to neuropathy.

control group

Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks

resistive training

Alice Ryan, PhD

Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.

Exercise Effect on Chemotherapy-Induced Neuropathic Pain

Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers

Thermal, mechanical, and vibration sensation by quantitative sensory testing

laboratory examination of skin biopsy samples for measurement of nerve fiber density

Baltimore VA Medical Center

Professor

Neoplasm Metastasis

Hematinics

Liver Extracts

In-situ liver split at time when portal vein ligature is performed

Intervention: Preoperative portal embolization (+/-ablation) followed by liver resection, or local resections and/or ablations followed by lobectomy, two-stage hepatectomy

The portal branches to the diseased side should be completely divided. The bile duct to the diseased side should not be divided. The parenchyma should be transected all the way through the transection plane and place a plastic sheet on the diseased transection surface.

In-situ split

Portal vein embolization is performed according to the intervention used at the different sites.

Portal embolization or ligation

Per Sandstrom, MD, PhD

Magnus Rizell, MD, Phd

Peter Noergard Larsen, PhD

Bard Rosak, MD, PhD

Bard Rosok, MD, PhD

Magnus Rizell

Magnus Rizell, MD, PhD

Per Sandstrom, PhD, MD

Gert Lindell, MD, PhD

Bengt Isaksson, MD, PhD

Bjarne Andnor, MD

Study Title Comparison of two different models of liver growth stimulation in advanced colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection

Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial

Study duration The planned duration of study participation for an individual subject from inclusion to follow-up are 3 years

Primary investigator:

Per Sandstrom (Linköping)

Number of subjects 100 patients randomized in a 1:1 randomization

Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring liver resection, but are not resectable in one step because of a future liver remnant/standardized total liver volume of \< 30 % extrahepatic metastatic disease is not an exclusion criteria if they can be addressed surgically in the future

Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients, primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with an acceptable level of complications and perioperative mortality.

To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal embolization or portal ligation leading to a shorter treatment period.

In addition the investigators aim to study if ALPPS may reach these goals without detectable or improved differences in tumor activity (PFS and OS), but with a shorter recovery and a higher proportion of patients reaching R0.

Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate resected compared to the previously established methods with portal ligation or embolization.

This increased resection rate will not reduce the R0 rate, or increase the rate of Clavien grade 4 complication or higher (H0).

The ALPPS approach will increase the growth rate compared to portal embolization/ligation measured one week after the primary intervention.

ALPPS Versus PVE/PL

Comparison of Two Different Models of Liver Growth Stimulation in Advanced Colorectal Liver Metastatic Disease, (LIGRO Trial) Enabling Liver Resection

Radical resection at resection line according to histopathology

Overall complications will be analysed as a composite endpoint (CEP) including: ascites, postresectional liver failure, bile leak, intra abdominal bleeding, intraabdominal abscess and mortality, all with a Clavien score of at least 3

Treatment time in days from PVE/PL or date of ALPPS op 1 until date of leaving hospital after final surgery.

Progression free survival according to randomization group.

Quality of life is measured by EORTC QLQ C-30 EQ5D ar 1,6,12,24 months.

An analysis with regard to hospitalisation rate and number of days in-ward between randomization arm.

For both the ALPPS and the portal vein embolization/ligation arm, resection is not allowed within the study if the patient is not reaching a future liver remnant of 30%.

For both groups carcinomatosis or more metastases making aiming radical resections impossible will be seen as failures.

Liver growth is measured with regard to the future liver remnant by measuring the kinetic growth rate by performing repeated CT or MRI at one week after portal vein embolization/ligation or after the first step of the ALPPS procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Detection of Five Common Cancers Using the ctDNA Analysing Test	NCT05227261	Cancer, Lung Cancer, Breast Cancer Liver Cancer, Colorec... Liquid Biopsy Circulating Tum... Cancer, Gastric		40 Years -	Gene Solutions
Early Detection of Five Common Cancers Using the ctDNA Analysing Test	NCT05227261	Cancer, Lung Cancer, Breast Cancer Liver Cancer, Colorec... Liquid Biopsy Circulating Tum... Cancer, Gastric		40 Years -	Gene Solutions
The IMPETUS Cancer Trial. A Technology Delivered Physical Activity Intervention in Cancer	NCT03036436	Cancer, Breast Cancer, Colorec... Malignancy	Intervention	18 Years -	University of Dublin, Trinity College
The IMPETUS Cancer Trial. A Technology Delivered Physical Activity Intervention in Cancer	NCT03036436	Cancer, Breast Cancer, Colorec... Malignancy	Intervention	18 Years -	University of Dublin, Trinity College
Change in Body Weight During Treatment of Advanced Colorectal Cancer	NCT04232748	Cancer, Colorec... Chemotherapy Ef... Weight Loss Prognosis	first line syst...	18 Years -	Tuen Mun Hospital
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2	NCT03615599	Cancer, Breast Cancer, Colorec... Cancer, Prostat...		30 Years -	Loma Linda University
Exercise Effect on Chemotherapy-Induced Neuropathic Pain	NCT02991677	Cancer, Breast Cancer, Colorec... Cancer, Lung Cancer, Ovarian	aerobic exercis... control group resistive train...	21 Years - 70 Years	Baltimore VA Medical Center
ALPPS Versus PVE/PL	NCT02215577	Colorectal Canc... Liver Metastase...	In-situ split Portal emboliza...	18 Years -	Regionalt Cancercentrum Väst
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2	NCT03615599	Cancer, Breast Cancer, Colorec... Cancer, Prostat...		30 Years -	Loma Linda University

Spots Global Cancer Trial Database for cancer, colorectal