NCT05236114Toboroz
GEMINI-NSCLC: NSCLC Biomarker Study
TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 5.
Rövid összefoglaló (regiszter, angolul)
GEMINI NSCLC Study is a non-interventional study that will be collecting clinical and molecular health information from patients with NSCLC who will receive longitudinal blood collection in addition to their standard of care therapy and disease surveillance with the goals of identifying the molecular evolution of lung cancer with standard of care therapy, and determining the utility of ctDNA dynamics to predict risk of recurrence and therapeutic outcomes.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1200 (tervezett)
- Első benyújtás
- 2022. jan. 12.
- Kezdés
- 2022. jún. 22.
- Elsődleges befejezés
- 2029. jún.
- Fő szponzor
- Tempus AI
- Betegségek
- Tüdőrák
- NCT-szám
- NCT05236114
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 1200
- 2022. jún. 22. és az elsődleges befejezés (2029. jún.) között
- 58 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
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Korábbi kezelés
- Patients with a secondary malignancy must have been both diagnosed > 2 years from the lung cancer of interest and have completed all therapy for that malignancy (including extended adjuvant therapy) > 2 years prior to diagnosis of the lung cancer of interest with the exception of the following:
Más betegség
- Patients without a known or suspected NSCLC diagnosis, or other disease processes such as sarcoidosis, lymphoma, or metastatic cancer from other sites.
Életkor
- Patients with superficial basal cell carcinoma of low-risk histology per NCCN Guidelines (Low-risk histologic subtypes include nodular, superficial, and other non-aggressive growth patterns such as keratotic, infundibulocystic, and fibroepithelioma of Pinkus) and low-risk for recurrence per NCCN Guidelines (location on trunk or extremities, size < 2 cm, primary (not recurrent), with well-defined borders) can be included even if they are diagnosed < 2 years from the lung cancer of interest.
- Patients with superficial squamous cell carcinoma of low-risk pathology per NCCN Guidelines (verrucous, keratoacanthomatous) and low-risk for recurrence per NCCN Guidelines (located on trunk or extremities; 2 cm in size; primary lesion (vs. recurrent); well to moderately differentiated; < 2 mm thick and no invasion beyond subcutaneous fat; negative for perineural invasion; and negative for lymphatic or vascular involvement) can be included even if they are diagnosed < 2 years from the lung cancer of interest.
Egyéb
- Not willing to have additional blood samples collected
A regiszterben nem jelölt feltételek
- For Cohort 1 Inclusion, the participant has/is:
- A known or suspected NSCLC treated with curative intent -(surgery with or without perioperative (neoadjuvant or adjuvant) therapy).
- Suspected NSCLC - Patients with a high index of suspicion for the diagnosis of NSCLC that is resectable may sign informed consent prior to undergoing diagnostic procedure at the discretion of the physician. NCCN Guidelines allow for clinical stage IA cancers to proceed directly to definitive surgery. Per NCCN Guidelines, if a preoperative tissue diagnosis has not been obtained, then an intraoperative diagnosis will be obtained. If a diagnosis of NSCLC is not confirmed and/or the tumor is not resectable, then the patient will be a screen failure.
- Undergone or planning to undergo a surgical resection - (Patients with stages I-IIIB who are resectable - per NCCN guidelines of resectability)
- Both patients who lack molecular abnormalities and those with identified molecular abnormalities may enroll. Choice of perioperative therapy is to follow SOC therapeutic guidelines for the participant's molecular and PD-L1 profile.
- 18 years old or older
- Willing and able to provide informed consent
- Willing to have additional blood samples collected during routine surveillance visits
- Must submit tumor sample representative of current disease
- For Cohort 1 Exclusion, the participant has/is:
- Patients with superior sulcus tumors who are candidates for preoperative concurrent chemoradiation.
- Stage III locally advanced and unresectable patients who are candidates for chemoradiation followed by immunotherapy.
- It is expected that all patients on the cohort will be treated with a definitive surgical resection. Thus, clinical stage IIIB and IIIC patients who subsequently demonstrate pathologically confirmed N3 nodal disease or T4 N2 or 3 per any confirmatory procedure listed in NCCN guidelines for which definitive chemoradiotherapy rather than surgery is recommended per NCCN Guidelines are not eligible.
- Patients who receive primary radiation (in lieu of surgery if they are not surgical candidates).
- For Cohort 2 Inclusion, the participant has/is:
- Histologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy. Palliative radiation (for instance for impending bony fracture or to control pain) is allowed at any time during the protocol at the physician's discretion.
- Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy). Patients who have had previous exposure to immunotherapy in the neoadjuvant or adjuvant setting are allowed to enroll as long as 12 months have elapsed since the prior exposure.
- Patients in surveillance on Cohort 1 are eligible to roll over to Cohort 2 at the time of recurrence as long as they have had histologic confirmation of recurrence and have been off immunotherapy for 12 months or greater and meet all other inclusion/exclusion criteria.
- Tumors that lack activating EGFR mutations (e.g., exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK fusions. Also, per NCCN Guideline recommended testing, tumors must also lack ROS1, BRAF, NTRK 1/2/3, METex14 skipping mutations, and RET for which there is available front-line targeted therapy. Only those patients with KRAS G12C mutations and ERBB2 (HER2) mutations with no contraindications to immunotherapy (PD-L1 1) for which there are no approved front-line targeted therapies and for whom immunotherapy would be the preferred front-line therapy are eligible.
- Patients may be enrolled with local molecular testing and those results will be provided.
- Patients may be enrolled with local molecular testing and those results will be provided.
- 18 years and older
- Willing and able to provide informed consent
- Willing to have additional blood samples collected during routine surveillance visits
- Must submit tumor sample representative of current disease
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (58)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| New York Oncology Hematology | Albany | Egyesült Államok | Toboroz |
| ThedaCare Regional Cancer Center | Appleton | Egyesült Államok | Toboroz |
| Morehouse School of Medicine (MSM) | Atlanta | Egyesült Államok | Toboroz |
| Piedmont Healthcare | Atlanta | Egyesült Államok | Toboroz |
| Johns Hopkins University | Baltimore | Egyesült Államok | Toboroz |
| University of Maryland | Baltimore | Egyesült Államok | Toboroz |
| New Jersey Cancer Center | Belleville | Egyesült Államok | Toboroz |
| PeaceHealth St. Joseph Medical Center-Bellingham | Bellingham | Egyesült Államok | Toboroz |
| The Center for Cancer and Blood Disorder | Bethesda | Egyesült Államok | Toboroz |
| Alabama Oncology | Birmingham | Egyesült Államok | Toboroz |
| Aultman Hospital | Canton | Egyesült Államok | Toboroz |
| Southern Illinois Hospital Services | Carterville | Egyesült Államok | Toboroz |
| UNC | Chapel Hill | Egyesült Államok | Toboroz |
| The Medical University of South Carolina | Charleston | Egyesült Államok | Toboroz |
| University of Virginia | Charlottesville | Egyesült Államok | Toboroz |
| TriHealth Cancer Institute | Cincinnati | Egyesült Államok | Toboroz |
| Clermont Oncology Center | Clermont | Egyesült Államok | Toboroz |
| OhioHealth Reseach Institute | Columbus | Egyesült Államok | Toboroz |
| Ohio State University | Columbus | Egyesült Államok | Toboroz |
| Cancer Care Specialists of Illinois | Decatur | Egyesült Államok | Toboroz |
| Duke University | Durham | Egyesült Államok | Toboroz |
| Hematology Oncology Associates of Central New York | East Syracuse | Egyesült Államok | Toboroz |
| Northwestern University | Evanston | Egyesült Államok | Toboroz |
| Mercy Clinic Oncology - Fort Smith | Fort Smith | Egyesült Államok | Toboroz |
| MemorialCare | Fountain Valley | Egyesült Államok | Toboroz |
| Frederick Health Regional System | Frederick | Egyesült Államok | Toboroz |
| Southeastern Medical Oncology Center (SMOC) | Goldsboro | Egyesült Államok | Toboroz |
| Hope and Healing Cancer Services | Hinsdale | Egyesült Államok | Toboroz |
| Hawaii Cancer Care | Honolulu | Egyesült Államok | Toboroz |
| Community Health Network | Indianapolis | Egyesült Államok | Toboroz |
| University of Iowa | Iowa City | Egyesült Államok | Toboroz |
| Cayuga Medical Center | Ithaca | Egyesült Államok | Toboroz |
| Mercy Clinic Oncology and Hematology - Joplin | Joplin | Egyesült Államok | Toboroz |
| Gundersen Health System | La Crosse | Egyesült Államok | Toboroz |
| OptumCare Cancer Care | Las Vegas | Egyesült Államok | Toboroz |
| Hope Cancer Care of Nevada | Las Vegas | Egyesült Államok | Toboroz |
| Cancer and Blood Specialty Clinic | Los Alamitos | Egyesült Államok | Fut, nem toboroz |
| UCLA | Los Angeles | Egyesült Államok | Toboroz |
| Taylor Cancer Research Center | Maumee | Egyesült Államok | Toboroz |
| Baptist Cancer Center | Memphis | Egyesült Államok | Toboroz |
| Icahn School of Medicine at Mount Sinai | New York | Egyesült Államok | Toboroz |
| Eastern CT and Hematology and Oncology Associates | Norwich | Egyesült Államok | Toboroz |
| Hightower Clinical | Oklahoma City | Egyesült Államok | Toboroz |
| Mercy Clinic Oncology and Hematology - Coletta | Oklahoma City | Egyesült Államok | Toboroz |
| Nebraska Cancer Specialists | Omaha | Egyesült Államok | Toboroz |
| Lake Regional Health System | Osage Beach | Egyesült Államok | Toboroz |
| Woodlands Medical Specialists | Pensacola | Egyesült Államok | Visszavonva |
| Cancer Care Specialists Reno | Reno | Egyesült Államok | Toboroz |
| OSF Saint Anthony Medical Center | Rockford | Egyesült Államok | Toboroz |
| Oregon Oncology Specialists | Salem | Egyesült Államok | Toboroz |
| Cancer Care Northwest | Spokane Valley | Egyesült Államok | Toboroz |
| Oncology Hematology Associates | Springfield | Egyesült Államok | Toboroz |
| Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center | Springfield | Egyesült Államok | Toboroz |
| Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center | St Louis | Egyesült Államok | Toboroz |
| Mercy Clinic Oncology and Hematology Sindelar Cancer Center | St Louis | Egyesült Államok | Toboroz |
| Oklahoma Cancer Specialists and Research Institute | Tulsa | Egyesült Államok | Toboroz |
| White Plains Hospital | White Plains | Egyesült Államok | Toboroz |
| Cancer Care Associates of York | York | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.