SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not 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: CT scans
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
- "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."
- 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
SIBYL studies whether a future version of the Guardant360 blood test can track how well cancer treatment is working. It measures cancer DNA in blood and compares changes with CT scans and other standard checks. The study is for adults with certain advanced lung, colon, rectal, or breast cancers.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Get standard treatment that works throughout the body and/or standard pills at the study site for the whole study.
- Be about to start your first standard cancer treatment, or have finished your first treatment and be about to start your second.
- Be able to understand the study and give written consent.
- Agree to share health information, with your identity removed, with study researchers at set times.
- Agree to give blood samples when you join and at later clinic visits.
- Have cancer confirmed by a tissue test: stage III or IV non-small cell lung cancer that cannot be removed by surgery, or stage IV colon or rectal cancer.
- Breast cancer also qualifies if it is stage III or IV and cannot be removed by surgery. Eligible types are HR+/HER2−, HR−/HER2+, HR+/HER2+, or triple-negative. These labels describe hormone receptors and HER2, a protein that can help cancer grow.
Who can't join
- Have had a prior solid tumor cancer or blood cancer within the past 5 years.
- Be expected to live 12 weeks or less.
- Be unable to give a starting blood sample during a routine treatment blood draw before starting standard treatment.
- Be in another trial or study testing a different gene-based test to detect or predict whether cancer treatment is working or cancer is getting worse.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria Each participant must satisfy all the following criteria to be enrolled in the study: 1. Age ≥18 years old 2. Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study 3. Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy 4. Able to understand, and capable of providing written consent to participate in the study 5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent 6. Are willing to provide blood samples at enrollment and at subsequent clinical visits 7. Have a histologically confirmed Index cancer that qualifies for inclusion, defined as: * Cohort 1: Unresectable Stage III/IV NSCLC (\~125) * Cohort 2: Stage IV Colorectal (\~125) * Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (\~55) * Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (\~55) * Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (\~55) * Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage. Exclusion Criteria Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study: 1. History of prior solid malignancy or hematological malignancy within five years of enrollment 2. Life expectancy ≤12 weeks 3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen 4. Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression
Study sites (1)
IL
- Orchard Healthcare Research Inc. · Skokie, IL 60077-1384Ira Oliff · Study contactMore trials in Skokie