What side effects are associated with this type of intervention?

Common treatments for unintended weight loss, particularly in the context of cancer detection and management, include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy can cause side effects such as nausea, vomiting, fatigue, hair loss, and increased risk of infection. Targeted therapies, like tyrosine kinase inhibitors, may lead to skin rashes, gastrointestinal issues, and liver toxicity. Immunotherapy can result in immune-related adverse effects, including skin reactions, colitis, and thyroid dysfunction. These treatments aim to manage the underlying cancer, which is often a cause of unintended weight loss.

What prior FDA approvals exist?

There are no specific FDA-approved treatments solely for unintended weight loss (UWL). However, treatments for conditions associated with UWL, such as cancer cachexia, include drugs like anamorelin, a ghrelin mimetic, which has shown promise in clinical trials. The GRAIL Galleri test is an investigational tool for early cancer detection through blood-based biomarkers, but it is not a treatment. Broadly, managing UWL involves addressing the underlying cause, such as cancer, and may include nutritional support and medications to stimulate appetite.

What other types of research exist?

Promising alternatives to the GRAIL Galleri Test for early cancer detection in patients with unintentional weight loss include liquid biopsy tests that analyze circulating tumor DNA (ctDNA) and other biomarkers. Examples include the Guardant360 test and the FoundationOne Liquid CDx test. These tests are designed to detect multiple types of cancer at early stages through blood samples, offering a non-invasive diagnostic option.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years post-enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial involves using a smart scale for regular weight tracking and a special blood test to detect cancer early. It targets people who lose weight without trying, aiming to find cancer sooner by combining weight monitoring with advanced blood testing.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Malignant UWL Detection

Secondary study objectives

Non-Malignant UWL Detection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Unintended weight loss (UWL) is often a symptom of underlying malignancies, making early detection crucial. The GRAIL Galleri test, which uses blood-based biomarkers to detect multiple types of cancer at an early stage, exemplifies a promising approach. This test identifies circulating tumor DNA (ctDNA) and other cancer-associated biomarkers in the blood, allowing for early intervention before the cancer progresses. Early detection through such mechanisms is vital for UWL patients as it can lead to timely treatment, potentially improving prognosis and survival rates by addressing the root cause of weight loss.

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