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EXoPERT EMERALD Clinical Study

EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects blood samples to help develop and test software that uses artificial intelligence (AI) to find several cancers early. The software studies tiny particles released by cells into the blood. The study is for adults age 45 or older with confirmed or suspected lung, breast, colon or rectal, pancreatic, or ovarian cancer.

The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. The software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) extracted from human plasma for the early detection of multiple cancers, including lung, ovarian, breast, pancreatic, and colorectal cancers.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 45 or older.
  • You have one of the listed cancers confirmed by a tissue sample, or suspected based on scans or other medical tests.
  • Your blood sample was collected before treatment for that cancer began.
  • You are willing and able to sign a form agreeing to join the study.
  • You are willing and able to follow the study requirements.

Who can't join

  • You had cancer diagnosed and treated within 5 years before agreeing to join.
  • You had surgery, hormone treatment, chemotherapy, or radiation for a recent cancer diagnosis within the past 6 months.
  • You have ever received bone marrow or stem cells from a donor, or an organ transplant.
  • You are pregnant or breastfeeding.
  • You agreed to join another cancer study and received treatment in it within the past 6 months.
  • You are currently being treated for drug abuse.
  • You received treatment, such as hormones, for lumps in the lung, breast, colon or rectum, pancreas, or ovaries before joining.
  • Your blood sample cannot be tested because it is contaminated, its red blood cells have broken down, or there is another sample problem.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Subject aged 45 years or older with a biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findings such as radiological, serological, endoscopic, or cytological findings, whose blood was collected prior to any systemic or definitive therapy for the cancer. * Subjects who are willing and able to provide written informed consent. * Subjects who are willing and able to comply with the study requirements. Exclusion Criteria: * Any history of cancer diagnosed and treated within 5 years prior to the date of consent. * Subjects with a history of previous cancer treatment via surgical resection, hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months for recent cancer diagnosis. * Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant. * Subjects who are pregnant or breastfeeding women. * Subjects who have consented and have undergone treatment in any other cancer related clinical trials withinthe past 6 months. * Subjects who are currently in active treatment for drug abuse. * Subjects who have received any treatment related to lung, breast, colorectal, pancreatic, or ovarian nodules, such as hormones prior to entering the study. * Unsuitable sample for testing due to contamination, hemolysis, etc.

Study sites (9)

CA

HI

KY

MD

NY