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NCT05935384 · ClinicalTrials.gov registry record

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

A clinical trial of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Guardant Health.

Recruiting
Registry status
470
Enrollment target
1
Study location

NCT05935384: Recruiting study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Guardant Health.

NCT05935384 is a study of Breast Cancer and Non-Small Cell Lung Cancer that is actively recruiting participants, run by Guardant Health. The registered enrollment target is 470 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05935384, a study of Breast Cancer and Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by Guardant Health.

RECRUITING
Registry status
470 participants
Enrollment target
1
Study location

Study Summary

The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.

Primary Outcome

The Primary Endpoint, sensitivity of ctDNA to detect disease progression, will be evaluated from all eligible subjects within the primary study cohorts (breast cancer, NSCLC, or CRC)

Interventions

  • DIAGNOSTIC_TEST Guardant360

Study Locations (1)

Illinois

  • Orchard Healthcare Research Inc. - Skokie

Trial Details

FieldValue
Enrollment Target 470 participants
Start Date 2023-10-25
Est. Completion 2030-12-30
Guardant Health

9 total trials

What NCT05935384 shows while recruiting

NCT05935384 is an observational study that tracks outcomes without assigning an intervention. The registered 470 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (83% lower).

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Guardant360 is the first listed.

NCT05935384 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT05935384 about?

NCT05935384 is a clinical study titled "SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation". The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcom...

What is the current status of trial NCT05935384?

This trial is currently recruiting. The enrollment target is 470 participants. The study started on 2023-10-25. Estimated completion is 2030-12-30.

What conditions does trial NCT05935384 study?

This clinical trial studies the following conditions: Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer.

What interventions are being tested in trial NCT05935384?

The interventions under investigation include: Guardant360 (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05935384?

This trial is sponsored by Guardant Health, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05935384 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05935384's enrollment target sits among peer trials

470 209th of 1224 higher than 1,015 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05935384, the US trial registry maintained by the National Library of Medicine. NCT05935384 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.