NCT04761783Befejeződött
BESPOKE Study of ctDNA Guided Immunotherapy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. aug. 15.
Rövid összefoglaló (regiszter, angolul)
This is a prospective data collection study of patients with advanced solid tumors who will receive standard of care immunotherapy (IO) and will be monitored with SIGNATERA™ testing. SIGNATERA™ test will be performed at baseline and during routine care. The test results will be part of assessing tumor response. The correlation between SIGNATERA™ test results and subsequent treatment decisions will be examined to compare actual treatment delivered against treatment decisions potentially impacted by SIGNATERA™ results. Treatment administered, tumor assessment results, time to progression, overall survival, physician questionnaires, and patient-reported outcomes will be collected/recorded.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 290 (tényleges)
- Első benyújtás
- 2021. febr. 16.
- Kezdés
- 2021. máj. 28.
- Elsődleges befejezés
- 2023. dec. 31.
- Fő szponzor
- Natera, Inc.
- Betegségek
- Vastagbélrák, Melanóma, Tüdőrák
- NCT-szám
- NCT04761783
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 290
- 2021. máj. 28. és az elsődleges befejezés (2023. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
A regiszterben nem jelölt feltételek
- Prospective Inclusion Criteria:
- Male or female patients 18 years of age or older at the time of signing informed consent form (ICF)
- Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:
- Melanoma
- Non-small cell lung cancer
- Colorectal cancer
- Patients must be clinically eligible and planned to receive therapy with an anti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1, anti-CTLA-4, or anti-PD-L1:
- Pembrolizumab (Keytruda)
- Nivolumab (Opdivo)
- Ipilimumab (Yervoy)
- Durvalumab (Imfinzi)
- Cemiplimab (Libtayo)
- Atezolizumab (Tecentriq)
- Avelumab (Bavencio)
- Patients must have measurable disease according to RECIST criteria, and at least one lesion that can be accurately measured in at least one dimension as >10 mm.
- Patients must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
- ECOG Performance status 0,1, or 2
- Able to read, understand and provide written informed consent
- Willing and able to comply with the study requirements
- Selected by their HCP to receive SIGNATERA testing according to the current evidence-informed schedule as part of their routine of practice
- Prospective Exclusion Criteria:
- Female patients that are pregnant
- History of bone marrow or organ transplant
- Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
- Serious medical condition that may adversely affect ability to participate in the study
- Has initiated Immunotherapy
- Control Arm Inclusion Criteria:
- Male or female patients 18 years of age or older at the time of signing informed consent form (ICF)
- Any patient with documented metastatic or locally advanced, unresectable cancer of the types within the following cohorts:
- Melanoma
- Non-small cell lung cancer
- Colorectal cancer
- Patients must be clinically eligible and planned to receive therapy with an anti-neoplastic agent that works by immune checkpoint blockade, anti-PD-1, anti-CTLA-4, or anti-PD-L1:
- Pembrolizumab (Keytruda)
- Nivolumab (Opdivo)
- Ipilimumab (Yervoy)
- Durvalumab (Imfinzi)
- Cemiplimab (Libtayo)
- Atezolizumab (Tecentriq)
- Avelumab (Bavencio)
- Patients must have measurable disease according to RECIST criteria, and at least one lesion that can be accurately measured in at least one dimension as >10 mm.
- Patients must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
- ECOG Performance status 0,1, or 2
- Able to read, understand and provide written informed consent
- Willing and able to comply with the study requirements
- Selected by their HCP to receive SIGNATERA testing according to the current evidence-informed schedule as part of their routine of practice
- Control Arm Exclusion Criteria:
- Female patients that are pregnant
- History of bone marrow or organ transplant
- Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
- Serious medical condition that may adversely affect ability to participate in the study
- Has initiated Immunotherapy
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Natera | San Carlos | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.