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Cancer Vaccine

GRAIL Galleri Test for Detecting Cancer in Unintended Weight Loss

N/A

Recruiting

Led By Jordan M Winter, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age range: from 40 to 80 years

Subjects must be mentally competent and must have the ability to understand and the willingness to sign a written informed consent document

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years post-enrollment

Awards & highlights

Study Summary

This trial is testing if detecting weight loss can help find cancer earlier, when coupled with the GRAIL Galleri test.

Who is the study for?

This trial is for English-speaking individuals aged 40-80 who have unintentionally lost weight and are willing to track it weekly using a smart scale. They must be mentally competent, able to consent, and have access to a compatible device. It's not for those pregnant, actively trying to lose weight, or with an active/recent cancer diagnosis.Check my eligibility

What is being tested?

The study is testing the GRAIL Galleri test alongside regular tracking of unintentional weight loss (UWL) in participants. The goal is to see if combining UWL detection with this early cancer detection test can identify malignancies sooner than usual.See study design

What are the potential side effects?

Since the intervention involves non-invasive monitoring through weight tracking and blood tests for cancer detection, there are minimal expected side effects directly from the interventions themselves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 80 years old.

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I can understand and am willing to sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years post-enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years post-enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years post-enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Malignant UWL Detection

Secondary outcome measures

Non-Malignant UWL Detection

Trial Design

1Treatment groups

Experimental Treatment

Group I: UWL and GRAIL Galleri TestingExperimental Treatment1 Intervention

Enrolled participants will have an initial blood sample taken and record their weights weekly on a FitBit Aria scale for three years to detect for UWL Those who unintentionally lost lost ≥5% from their baseline weight will be identified and have a GRAIL Galleri blood test, physical examination, imaging, and cancer screenings to test for malignancy

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

30,910 Total Patients Enrolled

University Hospitals Seidman Cancer CenterOTHER

4 Previous Clinical Trials

97 Total Patients Enrolled

Jordan M Winter, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Media Library

GRAIL Galleri (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05481697 — N/A

Unintended Weight Loss Research Study Groups: UWL and GRAIL Galleri Testing

Unintended Weight Loss Clinical Trial 2023: GRAIL Galleri Highlights & Side Effects. Trial Name: NCT05481697 — N/A

GRAIL Galleri (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05481697 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to register for this trial?

"This clinical trial seeks 1000 volunteers aged 40 to 80 with unintended weight loss. Participants must be mentally capable, able to comprehend the research rationale and procedures, as well as speak English fluently. Additionally, they should possess access to a compatible device for their Fitbit Aria Air smart scale throughout the study period in order to comply fully with all protocols."

Answered by AI

Is the current research endeavor recruiting elderly individuals as participants?

"This medical trial's inclusion criteria necessitates that participants are aged 40 - 80. Separately, there are 49 trials for minors and 207 clinical studies targeting the elderly."

Answered by AI

Are there any opportunities for recruitment into this research endeavor?

"Clinicaltrials.gov reveals that this research study is not currently recruiting participants, despite being initially listed on the 1st of January 2023 and last edited on the 28th of July 2022. However, other 309 trials are presently in search of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combin

2024. "Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05481697.