Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

100mg enteric-coated aspirin, taken daily

100mg enteric-coated placebo, taken daily

Placebo

Anne Murray, MD, MSc

The ASPREE Cancer Endpoint Study (ACES), an ancillary study of the ASPirin in the Prevention of Events in the Elderly (ASPREE) Study, will allow for the examination of the effect of daily low-dose aspirin (100 mg) compared to placebo, on specific DNA biomarkers and selected specific incident and recurrent cancer and metastases. The establishment of this ACES biobank will allow for the exploration of DNA-related molecular mechanisms of aspirin's protective effect against cancer, cancer associated mortality and metastases, using blood or saliva DNA specimens, urine, and tumor tissue.

The ASPREE Cancer Endpoint Study (ACES) is an ancillary study of the ASPirin in the Prevention of Events in the Elderly (ASPREE) Study, a 5 year randomized placebo- controlled trial of 100 mg of daily aspirin in 19,000 elderly in Australia and the US to determine whether the benefits of low dose daily aspirin outweigh the bleeding risks. The primary outcome of ASPREE is defined as prolongation of "disability-free life", measured as survival without physical disability or dementia. At present, the primary purpose of ACES is to: 1) collect information about participant cancer screenings, cancer diagnosis, and family history of cancer and to 2) establish a biologic specimen repository (biobank) for DNA and tumor tissue, and urine from the ASPREE large healthy aging population in the US and Australia for future use by ASPREE, NIA and NCI investigators, and academicians from the broader research community. At a time in the future and under separate application, the stored blood or saliva, urine, and tumor tissue, together with other information obtained about these participants (in relation to their health, lifestyle and other circumstances) will be analyzed to address specific questions regarding the association of biomarkers and major health outcomes including cancer.

ASPREE Cancer Endpoints Study

The ASPREE Cancer Endpoint Study (ACES) will allow for the examination of the effect of daily low-dose aspirin (100 mg) compared to placebo, on specific DNA biomarkers and selected specific incident and recurrent cancer and metastases. The establishment of this ACES biobank will allow for the exploration of DNA-related molecular mechanisms of aspirin's protective effect against cancer, cancer associated mortality and metastases, using blood or saliva DNA specimens, urine, and tumor tissue.

National Cancer Institute (NCI)

National Institute on Aging (NIA)

Monash University

Berman Center for Outcomes and Clinical Research

National Health and Medical Research Council, Australia

Bayer

Hennepin Healthcare Research Institute

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

This study also includes an exploratory biological ancillary study that aims to identify the gene expression variations that are determinant in terms of vulnerability/protection (cytogenetic and transcriptome), through the measurement of the level of biological chronic stress and epigenetic methylations of the NR3C1 and FKBP5 genes, in relation to adversity in childhood And to show the convergence between self-reported measures related to the presence of ACEs and attachment disorders with assays of chronic stress and epigenetic biomarkers.

Biological and epigenetic measures

Marion Trousselard, Pr

Christine Rotonda, PhD

Marion Trousselard, PR

Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase.

ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications.

The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.

This study also includes a biological ancillary study exploring sub-cellular mechanisms, using high-throughput sequencing to identify gene expression variations that are determinant in terms of vulnerability/protection (cytogenetics and transcriptome).

The objective of the ancillary study, coupled to the main study, is to show the convergence between self-reported measures related to the presence of ACEs and attachment disorders with assays of chronic stress and epigenetic biomarkers.

Adverse Childhood Experiences, Adaptation and Breast Cancer

Adverse Childhood Experiences, AdaPtatiOn and Breast Cancer

Hair cortisol levels via analysis of 100 hairs collected with the root and stored at 4°C

Percentage methylation of genes coding for directed analysis of target regions coding for NR3C1 and FKBP5 genes derived from whole blood, saliva and oral cells assessed using chromatin immunoprecipitation (ChIP) assays

The primary outcome was quality of life assessed with the Short Form Survey 12 (SF-12 scale).

The score ranges from 0 to 100, with a score above 50 indicating average quality of life, 40 to 49 indicating mild disability, 30 to 39 indicating moderate disability, and below 30 indicating severe disability.

The level of fear of cancer recurrence as assessed by the Cancer Recurrence Fear Inventory

Level of fatigue assessed by the Multidimensional Fatigue Inventory (MFI). It is a questionnaire with 20 items on a 5-point likert scale ranging from 1 "strongly disagree" (worth 1 point) to 5 "strongly agree" (worth 5 points). The score is calculated by summing the points on the scale. The higher the score, the more severe the fatigue.

Level of anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS).

This scale evaluates the level of anxiety in 7 items and the level of depression in 7 items, ranging from 0 to 3. A score greater than or equal to 10 indicates a definite level of anxiety or depression.

Attachment relationships were assessed using the Relationship Scales Questionnaire (RSQ).

The number of adverse childhood and adolescent experiences assessed using the Adverse Childhood Experiences International Questionnaire (ACE-IQ).

The total number of ACEs to which the participant has been "exposed" is summed to create an ACE score ranging from 0 (no ACEs) to 13. A score of 0 ACEs means a low level of adversity and a score of 13 means a major level of adversity.

The level of resilience estimated using the Brief Resilience Scale (BRS). The Brief Resilience Scale is a 6-item questionnaire. Each item is rated on a 5-point Likert scale. Higher scores indicate greater resilience.

Differences in resting RMSSD (root mean square of successive differences between normal heartbeats) values according to the status with or without ACE, performed via the Caducy (software)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ASPREE Cancer Endpoints Study	NCT01968798	Cancer	Aspirin Placebo	65 Years -	Hennepin Healthcare Research Institute
Adverse Childhood Experiences, Adaptation and Breast Cancer	NCT05843539	Adverse Childho... Cancer, Breast Attachment Styl... Resilience, Psy... Quality of Life Epigenesis, Gen...	Biological and ...	18 Years -	University of Lorraine
ASPREE Cancer Endpoints Study	NCT01968798	Cancer	Aspirin Placebo	65 Years -	Hennepin Healthcare Research Institute
Adverse Childhood Experiences, Adaptation and Breast Cancer	NCT05843539	Adverse Childho... Cancer, Breast Attachment Styl... Resilience, Psy... Quality of Life Epigenesis, Gen...	Biological and ...	18 Years -	University of Lorraine
Adverse Childhood Experiences, Adaptation and Breast Cancer	NCT05843539	Adverse Childho... Cancer, Breast Attachment Styl... Resilience, Psy... Quality of Life Epigenesis, Gen...	Biological and ...	18 Years -	University of Lorraine

Spots Global Cancer Trial Database for aces

Every month we try and update this database with for aces cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for aces

Every month we try and update this database with for aces cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aces cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.