Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Individuals without history of PDAC meeting any of the following criteria:

A. 2+ relatives with PDAC on same side of family; 2 are first degree related to each other and at least 1 is first degree related to subject; age ≥ 50 years or ≤10 years younger than earliest PDAC in family at diagnosis.

B. 2+ first degree relatives with PDAC; age ≥ 50 years or ≤ 10 years younger than earliest PDAC in family at diagnosis.

C. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age ≥ 50 years or ≤ 10 years younger than earliest PDAC in family at diagnosis.

D. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age ≥ 40 years.

E. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age ≥35 years.

F. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age ≥ 40 years.

Individuals without history of PDAC meeting any of the following criteria:

A. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history; age ≥50 years.

B. Two or more (2+) relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age ≥50 years or ≤10 years younger than earliest PDAC in family at time of diagnosis.

C. One (1) first degree relative with PDAC at age ≤45 years; ≤10 years younger than PDAC diagnosis in family member at time of diagnosis.

A. Individuals meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2); age ≥ 18 years.

A. Individuals without history of PDAC presenting for evaluation who do not meet any criteria for the other cohorts after collection of full family history and/or germline testing, eg. they have only 1 relative with PDAC; age ≥ 18 years.

Individuals with a personal history of PDAC meeting any of the following criteria (age ≥ 18 years for all subgroups):

A. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other.

B. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, PRSS1, STK11.

C. Diagnosed with PDAC at ≤ age 45.

Individuals with pancreatic cysts (age ≥ 18 years for all subgroups):

A. Individuals with a pancreatic cystic neoplasm (IPMN) and/or mucinous cystic neoplasm (MCN) and/or PanIN not meeting any criteria for Cohorts 1-3 or 6 (no personal history of PDAC, no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk present in cohorts 1C, 2A, 1D, 1E, and 1F).

B. Individuals with a pancreatic cystic neoplasm (IPMN) and/or MCN and/or PanIN without PDAC and with at least one of the pathogenic or likely pathogenic gene mutations present in cohorts 1C, 2A, 1D, 1E, and 1F and/or a first degree relative with PDAC.

Individuals with a personal history of pancreatitis meeting any of the following criteria (age ≥ 18 years for all subgroups):

A. Chronic pancreatitis. B. At least 2 episodes of acute pancreatitis.

Individuals with one of the following conditions and treatment naïve (age ≥ 18 years for all subgroups):

A. Biopsy-proven, clinical stage I-II PDAC and candidate for surgical resection.

B. Clinical findings suspicious for early stage PDAC prior to biopsy.

Harmeet Dhani, MD, M.Sc

Rebekah White, MD

Harmeet Dhani, MD

Hoon David, PhD

Thomas Lomis, MD

Priyanka Kanth, MD

Steven Hughes, MD

Bhanu Visvalingam, MD

Sapna Syngal, MD

ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC).

Those with elevated risk for PDAC can include individuals with intraductal papillary mucinous neoplasms, family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, and a personal or family history of pancreatitis.

The goal of the study is to compare the performance of ExoVerita™ assay in early detection of PDAC to current standard-of-care methods of surveillance.

Biological Dynamics, Inc. has developed a non-invasive blood test ("liquid biopsy") that can identify early-stage disease with high sensitivity and specificity. The proprietary ExoVerita™ assay uses alternating current electric (ACE) field to isolate extracellular vesicles (EVs) for differentiated multiomics applications and includes an optimized machine learning algorithm to identify a panel of EV-bound protein biomarkers in patient's plasma in order to detect PDAC at earlier stages.

ExoLuminate is a prospective, multi-center, observational registry study designed to evaluate the non-inferiority of the performance of the ExoVerita™ assay in detecting pancreatic ductal adenocarcinoma (PDAC) in high-risk or clinically-suspicious populations in comparison to standard-of-care methods.

The study is planned to recruit a minimum of 1000 U.S. adults over 3-years (with a 2-year follow-up for data collection).

Eligible subjects will be evaluated using the ExoVerita™ assay through blood donation(s) at specified time intervals. Overall, this study poses minimal risk to subject.

ExoLuminate Study for Early Detection of Pancreatic Cancer

Exoluminate Study: Observational Registry Study to Assess Exo-PDAC Assay Performance for Detection of Pancreatic Adenocarcinoma (PDAC) in High-Risk or Clinically Suspicious Patients

Evaluation of stage distribution (SEER) at diagnosis

Medical College of Wisconsin

Dana-Farber Cancer Institute

Biological Dynamics

Medical Director

All Drugs and Chemicals

Immunomodulating Agents

Collect peripheral blood sample of 40 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect EV-score by EV-array. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST.

Clinical data, including tumor stage, metastastic organ, regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

EV-array

lin shen, MD

cheng zhang, PhD

xiaotian zhang, MD

To vertify the function of EV-score on predicting \& monitoring immunotherapeutic outcomes of GC

Our previous work identified four plasma EV-derived proteins and combined them to generate a signature score that robustly predicting immunotherapeutic outcomes at baseline and dynamically monitoring disease progressions along with the whole treatment.

Hence in this stuty, we plan to recruit a prospective cohort to support our conclusions, and provide possible method to realize predicting and monitoring immunotherapeutic outcomes of GC.

Prospectively Predict the Efficacy of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy

A Clinical Study Initiated by Investigator:Prospectively Predict the Efficacy of Precise Treatment of Gastrointestinal Tumors Based on Peripheral Blood Multi-omics Liquid Biopsy

EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV

Analysis patients' survival with different EV-Score.

Shen Lin

Director of GI oncology Affiliation: Peking University

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Supplementary blood samples collection during the normal follow up of the patients

Samuel AMINTAS

Véronique VENDRELY

Routine clinical and radiological assessment of response of patients with rectum cancer to neoadjuvant chemoradiotherapy does not allow accurate identification of complete pathological response, and leads to frequent false positive and negative results. Molecular markers reflecting the initial and post-nCRT status of the tumor would be ideal to select patients eligible for organ preservation. This project will test the detection of tumor extracellular vesicles (EVs) in liquid biopsy as a reliable marker for the identification of poor versus good responders to nCRT.

Neoadjuvant treatment (NT) followed by total mesorectum excision (TME) constitues the gold standard for locally advanced carcinoma of the low and middle rectum. When good clinical response to NT is obtain, strategies with organ preservation, including close surveillance without immediate surgery or transanal local excision, can spare patients with the highly morbid and functional cost of TME. Current assessment of good responders relies on the downstaging and/or downsizing of the tumor as evaluated by MRI imaging and clinical exam. This strategy is prone to errors in more than 1/3 cases. Better assessment of tumor response to NT would better select patients eligible for organ preservation strategies. This study will use the detection of tumor extracellular vesicles (EVs) in liquid biopsy to identify good response of rectum cancer to neoadjuvant treatment. Tumor EVs will be detected in the blood of the patients at different times of their regular management (before, during and after NT). Protein content or tumor DNA in EVs will be detected after tumor DNA sequencing in the primary biopsies. Response will be assessed according to tumor EV presence or absence in the blood. As EV quantification is possible, kinetics of their detection will help response assessment and patient follow-up.

A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer

Presence of onco-exosomes and / or exoDNA according to the response to the neoadjuvant treatment by chemotherapy alone or followed by radiochemotherapy of rectal cancer

To evaluate whether the kinetics of detection of oncoexosomes and exoDNA is a predictor of the response of rectal cancer to neoadjuvant treatment

To evaluate whether the initial mutational profile of the tumor is a predictor of the response of rectal cancer to chemotherapy and radiochemotherapy neoadjuvant treatment

University Hospital, Bordeaux

Behaviors and Mental Disorders

Anxiety Disorders

Depressive Disorder

Depression

Group intervention on Mindfulness-Based Cognitive Therapy classic program plus 4 monthly consolidation sessions of 90 minutes each.

Experimental group: MBCT is program developed by Zindel Segal, Mark Williams, and John Teasdale , based on Jon Kabat-Zinn's Mindfulness-based Stress Reduction (MBSR) program. Participants learn to acknowledge their unhelpful thoughts and feelings, allowing the mind to move from an automatic and spiraling thought pattern to a more conscious emotional processing. Mindfulness practices include breath awareness, sitting and walking meditations, and mindful yoga. In this study, the following MBCT structure will be followed: group setting of 12 participants (maximum); 8 online weekly meetings of 2 hours via a videoconference platform (e.g., Cisco Webex), each one mediated by a trained mindfulness instructor(s); daily home practice of the learned skills; 2 hours of retreat after the fifth week; 6 months of home practice; 4 monthly consolidation sessions of 90 minutes each.

Mindfulness Based Cognitive Therapy (MBCT)

In this case, participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral, and intervention for people with significant distress difficulties. Regarding pharmacological intervention, medication intake will be monitored during the study and changes will be registered. The engagement in non-pharmacological interventions such as psychological and psychosocial interventions will also be monitored.

Treatment as Usual

Eunice Silva, PhD

Carmen Jerónimo, PhD

Eunice D Silva, PhD

Rui Henrique, PhD

Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction (MBSR), mindfulness-based cognitive therapy (MBCT), mindfulness-based cancer recovery (MBCR), have been showing promising results in different health-related and psychosocial outcomes in the context of cancer. More recently, the possibility of delivering MBIs using technological tools and resources, such as internet and applications, has been receiving much attention, also accompanied by promising findings. However, few randomized controlled studies have been conducted and published to date. Moreover, few studies have addressed the long-term stability and trajectory of gains across time. Also, even though prior evidence had suggested that face-to-face MBIs might modulate several biological markers (e.g., pro-inflammatory gene expression and inflammatory signaling; telomere length), as far as we know, no previous study addressed the impact of online MBIs on biological indices, especially on extracellular vesicles (EVs).

As primary objective, this study aims to investigate the effects of an internet-based MBCT intervention (vs. Treatment as Usual - TAU) on EVs (objective measure), as well as on psychological distress (subjective measure), considering a sample of distressed people with history of breast, prostate, and colorectal cancer.

As secondary objective, this study aims to investigate the effects of this same intervention on psychosocial outcomes, including quality of life, fear of cancer recurrence, emotion suppression, mindfulness, sleep quality, posttraumatic growth, health-related behaviours (physical activity; smoking habits), and perceived social support. The biological secondary outcomes studied will be: inflammatory response genes interleukins (ILs, IL-1, IL-6, IL-8, IL-10), interferon gamma (IFN-γ), tumour necrosis factor (TNF), and c-reactive protein (CRP); telomerase activity; antigens related to cancer (cancer antigen - CA 15-3; prostate-specific antigen - PSA; carcinoembryonic antigen - CEA); other health-related markers (adrenocorticotropic hormone - ACTH; erythrocytes number; hemoglobin glycosylated).

At baseline, everyone (participants, study coordinator, mindfulness instructor(s), research assistant, and statistician) will be blinded to conditions as it is expected to occur before randomization. Once participants are randomized, the study coordinator will inform them of the group assignments, and all of them will become unblinded to the conditions. Due to the specificities of this type of study and intervention, it is not possible to guarantee the blinding of personnel and participants.

The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients - Study Protocol

The Modulatory Role of Internet-supported Mindfulness-based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer: A Study Protocol for a Two-armed Randomized Controlled Trial

Isolated by ultracentrifugation with sucrose cushion. The collected EVs will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL).

Measured with Depression Anxiety Stress Scales-21 - DASS-21, a self-report and public domain questionnaire that evaluates negative affective states. It is composed of 21 items, 7 focused on depression, 7 on anxiety, and 7 on stress. Each item is rated on a 4-point Likert-type scale, wherein in 0 represents "did not apply to me at all" and 3 represents "applied to me very much or most of the time". The score for each subscale ranges between 0 and 21. In the current study, a total score will be computed by summing all items, with higher scores being indicative of higher self-reported psychological distress.

Using an immunoassay analyser (units/mL).

Assessed by quantitative RT-PCR (TaqMan™ Gene Expression Assays).

This indicator assesses erythrocytes number (million/mm3) from blood samples (Sysmex XN).

This indicator assesses PCR (mg/L) from blood samples.

This indicator assesses telomerase activity (units) from blood samples.

This indicator assesses High Performance Liquid Chromatography - HPLC, (mmol/mol) from blood samples.

Measured with Clinical Outcome Routine Evaluation - Outcome Measure, (CORE-OM) , a self-report measure of global distress (GD), comprising 34 items and four domains: subjective well-being, commonly experienced problems or symptoms, social/life functioning, and risk to self and others. The measure is scored on a 5-point scale ranging from 0 ('not at all') to 4 ('all the time'). The measure is suitable for use across a wide range of settings, it has been validated in different adult population with mental health problems, and it is sensitive to change.

Measured by World Health Organization Quality of Life - Bref - WHOQOL-Bref, a questionnaire suitable for epidemiological and clinical trials, which assesses quality of life as proposed by WHO. It is composed of 26 items distributed in one general facet and four domains (physical health, psychological, social relationships, and environment). Each item is rated on a 5-point Likert-type scale with higher scores being indicative of better self-reported quality of life (scoring procedures are available here: https://www.who.int/mental_health/media/en/76.pdf).

Measured by a 7-item Fear of Cancer Recurrence - FCR-7 (PT version not yet available), a 7-item scale assessing fear of cancer recurrence in a 5-point Likert scale ranging from 1 (not at all) to 5 (all the time). It had demonstrated good psychometric properties. We will translate, adapt and validate this measure, following the usual procedures to adapt psychological measures.

Satisfaction with Social Support Scale - SSSS, a 15-item scale assessing social support satisfaction discriminating four dimensions: satisfaction with friends/friendships, intimacy, satisfaction with family and social activities.

Emotion Regulation Questionnaire - ERQ) , - Only the subscale of emotion suppression composed of 4-items will be used. The items are rated in 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

Measured by Mindfulness Five Facet Mindfulness Questionnaire - FFMQ, a 39 items questionnaire that assess mindfulness and self-awareness states in everyday life, which are organized in five different facets/subscales: observing, describing, acting with awareness, nonreactivity to inner experience, and nonjudging of inner experience. Each item is rated on a 5-point Likert-type scale ranging from 1 (never or very rarely true) and 5 (very often or always true).

This interview assesses the psychotherapeutic changes perceived by participants after psychological intervention. The interview questions explore the changes that a person has noticed since therapy began, what the person attributes these changes to, and helpful and unhelpful aspects of therapy, in a qualitative way.

Measured with Fageström Test for Nicotine Dependence - FTND. This instrument assesses nicotine dependency with 6 items (rated from 0 to 2 or 3). The total score range is 1-10, with higher values meaning higher nicotine dependency.

Measured with International Physical Activity Questionnaire - Short Form - IPAQ-SF. This instrument assesses physical activity in 7 items, with higher scores meaning higher level of physical activity.

Measured with Basic Scale on Insomnia complaints and Quality of Sleep - BaSIQS - This is a self-report measure that focus on evaluating sleep quality, as well as problems to fall asleep and maintain sleep. It encompasses 7 items rated in a 5-point Likert-type and the total score ranges between 0 and 28, with highest values indicating poor sleep quality. Satisfactory psychometric properties were reported in the original study with Portuguese higher education students, but also on community and clinical samples

Measured with Posttraumatic Growth Inventory - PTGI, which is a self-report questionnaire that evaluates positive psychological change in people experiencing traumatic events. It includes 21 items and each item is rated on a 6-point Likert-type scale ranging from 0 ("I did not experience this change as a result of my crisis") to 5 ("I experienced this change to a very great degree as a result of my crisis"). Total score ranges between 0 and 105, with higher values being indicative of a greater degree of posttraumatic growth.

European Commission

University of Coimbra

VTT Technical Research Centre, Finland

University of Oulu

Linnaeus University

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Dimercaprol

Single arm of Olmutinib, staring dose of 800 mg

Patients to be provided with Olmutinib 800mg (2 x 400 mg tablets) once daily (QD)

Olmutinib

Kye Young Lee

The purpose of this study is to evaluate the efficacy of Olmutinib(Olita®) in patients with T790M-positive non-small cell lung cancer (NSCLC) confirmed using DNA extracted from extracellular vesicles of bronchoalveolar lavage fluid.

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of Olmutinib(Olita®) administered to patients with T790M-positive NSCLC confirmed using DNA extracted from extracellular vesicles in bronchoalveolar lavage fluid as measured by objective response rate (ORR).

Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA

Phase II, Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy of Olmutinib(Olita®) in Patients With NSCLC Who Harboring T790M Mutation Confirmed Using DNA Extracted From Extracellular Vesicles in Bronchoalveolar Lavage Fluid

defined as the proportion of patients who achieved complete remission(CR) or partial remission(PR) based on RECIST version 1.1

defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1

defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first

Hanmi Pharmaceutical Company Limited

Konkuk University Medical Center

Professor

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Prostatic Neoplasms

Stress, Psychological

Group therapy based on Mindfulness Based-Cognitive Therapy (MBCT).

Group therapy based on Emotion Focused Therapy for Cancer Recovery (EFT-CR).

Treatment as Usual is the condition in which participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral and intervention for people identified with significant distress difficulties.

MBCT is a program developed by Zindel Segal, Mark Williams and John Teasdale. During MBCT patients learn to decenter their negative thoughts and feelings, allowing the mind to move from an automatic thought pattern to conscious emotional processing. Mindfulness practices included in this program are breath awareness, body scan, sitting and walking meditation, and mindful yoga. The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions.

Mindfulness Based-Cognitive Therapy (MBCT)

EFT-CR is an evidence-based approach to psychotherapy, which combines aspects of person-centered, gestalt and existential therapies with contemporary emotion theory and dialectical constructivism (Elliott et al, 2004, Rice \& Greenberg, 1984). On EFT-CR, therapist follows the client experience and guides the process, proposing therapeutic tasks when specific client behaviors occur. EFT-CR uses a set of emotion change principles which guide a process of emotional deepening process, from undifferentiated distress to secondary reactive emotions to primary maladaptive emotions to core pain and thence to primary adaptive emotions and emotional transformation (Elliott \& Greenberg 2016). The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions.

Emotion Focused Therapy Group for Cancer Recovery (EFT-CR)

Treatment as usual (no intervention)

Goreti Sales, PhD

Background: There is some evidence demonstrating the effect of psychological interventions in improvements in health biological parameters. To best of our knowledge, no study had addressed the impact of any psychological intervention on extracellular vesicles. In addition, Mindfulness-Based Cognitive Therapy (MBCT) and Emotion Focused Therapy for Cancer Recovery (EFT-CR) in the group have never been explored regarding extracellular vesicles and the effectiveness of these was not compared yet.

Objectives:

1. To explore and compare the effect of MBCT and EFT-CR on biological parameters and psychological variables in distressed people who have had breast, prostate and colorectal cancer;
2. In addition, we will explore the acceptability through recruitment and retention rates of MBCT and EFT-CR in group and evaluate whether these interventions are appropriate for a larger clinical trial.

Methods: The design of this study is a parallel randomized controlled trial. Participants will be randomized into MBCT, EFT-CR or usual care. Outcome measures will be assessed before, at the end of the intervention (8 weeks) and follow-ups (24 and 52 weeks from the baseline moment).

Hypotheses: The researchers expected that both interventions will have an effect on extracellular vesicles and other study biomarkers as well as improvements in psychological outcomes, compared to treatment as usual (TAU) group. Regarding the comparative effectiveness, we did not have evidence to hypothesize which one of the interventions will be superior in both biological (extracellular vesicles) and psychological outcomes.

Contribution for practice: The results of this preliminary study would permit to know if there are benefits of these psychological interventions on changes in extracellular vesicles and on psychological outcomes related to health. In addition, this study will permit to determine the acceptability of conducting a larger randomized controlled trial.

only the investigator responsible for the eligibility assessment would be blind (in the recruitment, in order to assess eligibility to enter the study), before the randomization.

Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer

Impact of Mindfulness-Based Cognitive Therapy and Emotion Focused Therapy Group for Cancer Recovery Interventions on Extracellular Vesicles and Psychological Distress in People Who Had Breast, Colorectal or Prostate Cancer: A Preliminary Parallel Randomized Controlled Trial

The collected extracellular vesicles will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL). NTA measures Brownian movements on a particle-by-particle basis tracking movements by image analysis. Additionally, miR21-5p - a brain related microRNA - will be measured to ascertain for the extracellular vesicle's origin. The latter will be achieved by isothermal DNA amplification method, and data will be measured by luminescence (in RLU - relative light unit).

This self-report instrument assess the depressive, anxiety and stress symptoms in a 4-points likert scale, from 0 to 3, with higher values representing higher depression, anxiety and stress symptoms

This indicator assess CA 15-3 (units/mL) using an immunoassay analyzer

This indicator assess PSA (ng/mL) using an immunoassay analyzer

This indicator assess CEA (ng/mL) using an immunoassay analyzer

This indicator assess ACTH (pg/mL) using an immunoassay analyzer

These indicators assess inflammatory response genes in plasma by Quantitative RT-PCR assays of the same individuals using TaqMan™ Gene Expression Assays

This indicator assess erythrocytes number (million/mm3) from blood samples(Sysmex XN)

This indicator assess PCR (mg/L) from blood samples

This indicator assess telomerase activity (units) from blood samples

This indicator assess HPLC (mmol/mol) from blood samples

This self-report measure assesses global distress in four domains: subjective well-being, symptoms, social/life functioning, risk to self and others, rated in 5-points likert scale from never to always. Higher scores meaning higher psychological suffering

These self-report instrument assess perceived quality of life related to the cancer, in a 5-points likert scale, from 0 to 4, with higher value indicated higher quality of life

These self-report instruments assess perceived spiritually related to the cancer in a 5-points likert scale, from 0 to 4, with higher value indicated higher well-being

This self-report instrument assess the fear of cancer recurrence, rated in a 5-points likert scale, with higher values indicated higher fear of recurrence

This self-report instrument assess the perceived level of social support, rated in a 5-points likert scale, with higher values meaning higher social support

This self-report measure assess the emotion regulation processes rated in a 7-points likert scale, with higher values representing higher emotional suppression

This self-report measure assess the impact of significant events, rated in a 5-points likert scale, with higher scores meaning higher negative impact of the event

This self-report measure assess the mindfulness and awareness skills, rated in a 6-points likert scale with higher scores indicating higher attention and awareness

This self-report measure assess the self-compassion skills, rated in 5-points likert scale, with higher scores indicating higher self-compassion

This interview assesses the psycho-therapeutic changes perceived by participants after psychological intervention. The interview questions explore the changes that a person has noticed since therapy began, what the person attributes these changes to, and helpful and unhelpful aspects of therapy, in a qualitative way. In addition, the participants identified therapeutic changes as result of the therapy and are asked to rate these changes in three scales: expected change (1: change totally expected; 5: totally unexpected); change without therapy (1: the change would not have happened; 5: change would happen for sure); and the value of the change (1: nothing important; 5: extremely important).

This instrument assesses nicotine dependency with 6 items (rated from 0 to 2 or 3). The total score range is 1-10, with higher values meaning higher nicotine dependency

This instrument assesses physical activity in 7 items, with higher scores meaning higher level of physical activity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ExoLuminate Study for Early Detection of Pancreatic Cancer	NCT05625529	Pancreas Cancer Exosomes Extracellular V... Pancreatic Neop...		18 Years -	Biological Dynamics
Prospectively Predict the Efficacy of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy	NCT04993378	Advanced Gastri... Immunotherapy	EV-array	18 Years -	Peking University
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer	NCT04852653	Rectal Cancer Liquid Biopsy	Supplementary b...	18 Years -	University Hospital, Bordeaux
The Modulatory Role of Internet MBCT on Extracellular Vesicles and Distress in Cancer Patients - Study Protocol	NCT04727593	Cancer	Mindfulness Bas... Treatment as Us...	18 Years - 65 Years	Instituto Portugues de Oncologia, Francisco Gentil, Porto
ExoLuminate Study for Early Detection of Pancreatic Cancer	NCT05625529	Pancreas Cancer Exosomes Extracellular V... Pancreatic Neop...		18 Years -	Biological Dynamics
Olmutinib Trial in T790M (+) NSCLC Patients Detected by Liquid Biopsy Using BALF Extracellular Vesicular DNA	NCT03228277	Non Small Cell ...	Olmutinib	19 Years -	Konkuk University Medical Center
Impact of Group Psychological Interventions on Extracellular Vesicles in People Who Had Cancer	NCT04298398	Cancer	Mindfulness Bas... Emotion Focused... Treatment as us...	18 Years - 65 Years	Instituto Portugues de Oncologia, Francisco Gentil, Porto

Spots Global Cancer Trial Database for extracellular vesicles