Project CADENCE (CAncer Detected Early caN be CurEd)

NCT05633342 | Unknown

• 1 other identifier: MX-011-219
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

With existing evidence showing the difference in miRNA expression levels between non-cancer and cancer groups, the investigators assume that levels of DNA methylation, RNA expression as well as protein concentration will also be dysregulated during disease progression. Combining the power of multi-omic cancer biomarkers, the investigators hypothesize that the sensitivity and specificity of MiRXES MCST can be significantly improved compared to existing multi-cancer diagnostic tests. In this study, the investigators propose to develop and validate blood-based, multi-cancer screening tests through a multi-omics approach.

Conditions

Thoracic Cancer; Ovarian Cancer; Liver Cancer; Prostate Cancer; Gastric Cancer; Colorectal Cancer; Breast Cancer; Esophageal Cancer; Pancreatic Cancer

Keywords

MCED; Diagnostic Tests; MiRNA; CfDNA; CtDNA

Outcome Measures

Primary Outcomes (6)

• To discover novel intracellular RNA and methylated DNA cancer biomarkers in fresh frozen tumor tissues.

  through study completion, an average of 2.5 years

• To select the best-performing multi-omic single-cancer, biomarker panels for each of the cancer types, and develop the corresponding Single-Cancer Early detection Algorithms (SCEAs).

  through study completion, an average of 2.5 years

• To discover and validate novel cell-free RNA and methylated cell-free DNA cancer biomarkers in the peripheral blood of cancer patients.

  through study completion, an average of 2.5 years

• To develop the best-performing multi-omic multi-cancer biomarker panel by integration and/or optimization of single-cancer panels and develop the corresponding Multi-Cancer Early detection Algorithm (MCEA).

  through study completion, an average of 2.5 years

• To develop in vitro diagnostic assay(s) for the Multi-Cancer Screening Test (MCST) and if appropriate Single-Cancer Screening Tests (SCSTs).

  through study completion, an average of 2.5 years

• To evaluate the clinical performance (AUC, sensitivity, specificity, tissue of origin) of the MCST and if appropriate SCSTs to discriminate cancer cases from control groups.

  through study completion, an average of 2.5 years

Secondary Outcomes (1)

• Secondary outcome: • To explore the relationship between MCST/SCSTs with clinical outcomes based on the collection of longitudinal follow-up information from medical records.

  through study completion, an average of 2.5 years

Study Arms (4)

Healthy average-risk cohort

Individuals representing the general population who self-declare to have no cancer history and have no indications suggestive of underlying cancer development. Subjects will be recruited from a state-of-the-art population study.

Increased-risk (genetic/familial) cohort

Individuals carrying certain germline mutations that predispose the subjects to an increased risk of having cancer than the general population. Subjects will be recruited from Cancer Genetics Service (CGS).

High-risk cohort

Individuals diagnosed with diseases that have a high risk of progressing to cancer.

Malignant cohort

Individuals diagnosed with cancer.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be carried out in 4 phases, namely Phase 1A, 1B, 1C, and 1D. Phase 1A and 1B will be carried out in parallel. Upon the completion of Phase 1A and 1B, Phase 1C will be initiated, followed by Phase 1D, which is the final phase of this study. All four phases involve participant recruitment (except Phase 1A), sample and data collection, and sample data analysis. Subjects recruited for CADENCE will be divided into four groups: (1) Healthy average-risk (2) Increased-risk (3) High-risk and (4) Malignant.

You may qualify if:

• Healthy average-risk cohort Individuals representing the general population who self-declare to have no cancer history and have no indications suggestive of underlying cancer development. Subjects will be recruited from a state-of-the-art population study.
• Increased-risk (genetic/familial) cohort Individuals carrying certain germline mutations that predispose the subjects to an increased risk of having cancer than the general population. Subjects will be recruited from Cancer Genetics Service (CGS).
• High-risk cohort Individuals diagnosed with diseases that have a high risk of progressing to cancer.
• Malignant cohort Individuals diagnosed with cancer. Wherever possible, samples for the 'Malignant group' should have a representation of each cancer stage.

You may not qualify if:

• Pregnant or lactating (self-declaration), unwilling or unable to provide signed informed consent and has or had received chemotherapy or radiotherapy for cancer treatment and/or any other cancer-related treatment.

Sponsors & Collaborators

• MiRXES Pte Ltd: lead

Study Sites (1)

Biopollis, Helios

Singapore, 258710, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A total of 30ml of whole blood will be collected in four blood tubes (3 ml in one EDTA tube + 27ml in three Streck Cell-free RNA BCT tubes). Collected blood samples are to be kept at room temperature and processed within 24 hours. All samples are to be processed to obtain separated portions of red blood cells, buffy coat, platelet-rich plasma, and platelet-poor plasma. All samples will be labeled with de-identified subject code and stored at -80°C.

MeSH Terms

Conditions

Ovarian Neoplasms; Liver Neoplasms; Prostatic Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Esophageal Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Head and Neck Neoplasms; Esophageal Diseases; Pancreatic Diseases

Study Officials

• Cheng He, PhD

  MiRXES Pte Ltd

  STUDY DIRECTOR

Central Study Contacts

Yvanka Gilliam, PharmD

CONTACT

+6581146906; yvankagilliam@mirxes.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: December 1, 2022
• Study Start: July 7, 2022
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

SG (1)