SIBYL: Sıvı Biyopsi Değerlendirmesiyle Tedavi Yanıtının İzlenmesi

Sade dilde özet

Bu çalışma, kanser tedavisine verilen yanıtın Guardant360 adlı sıvı biyopsi (liquid biopsy) kan testiyle izlenip izlenemeyeceğini değerlendirmektedir. Çalışmaya küçük hücreli dışı akciğer kanseri (non-small cell lung cancer), kolorektal kanser (colorectal cancer) ve meme kanseri (breast cancer) gibi ileri evre kanserleri olan 18 yaş ve üzeri hastalar alınmakta ve katılımcılardan düzenli aralıklarla kan örnekleri toplanmaktadır. Çalışma faz uygulanmayan (gözlemsel) bir çalışma olup halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Katılımcı alıyor

Sponsor

Guardant Health, Inc.

Müdahale

Guardant360

Başlangıç

25.10.2023

Tahmini bitiş

30.12.2030

Ülkeler

United States

İlgili genler

Merkezler

• Skokie, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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