TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx) EVO
Study Details
Study Description
Brief Summary
TRACERx EVO is a programme of work using a prospective observational cohort study of participants with early- and late-stage non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
TRACERx EVO is a programme of work linked to an observational cohort study that consists of early and late-stage lung cancer. Participants will receive anti-cancer therapies (systemic therapies, radiotherapy and surgery, as per local and national guidelines). This study involves collecting a large amount of data, covering demographic and clinical characteristics, data throughout their follow up from the time of baseline/surgery, genomics and all other laboratory results using their blood, tissue, urine, saliva and stool samples. Data would also be retrieved from participant medical records. As such, there will be a wide range of analyses
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort A 300 participants with early stage resectable I-IIIB NSCLC |
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| Cohort B 200 participants with unresectable late stage IIIB-IIIC or de novo metastatic disease. |
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| Cohort C 50-100 participants with stage I-IV SCLC. |
Outcome Measures
Primary Outcome Measures
- Disease Free Survival [5 years]
- Progression Free Survival [5 years]
- Overall Survival [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cohort A, B and C :
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Written Informed consent
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Agreement to be followed up (including on-study assessments and sample collection) every 3 months in the first 2 years and then 6 monthly.
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Agreement to be followed up at a TRACERx EVO site
Cohort A:
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Participants ≥18 years of age, with early stage I-IIIB NSCLC disease who are eligible for primary surgery
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Pathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g., diagnosis determined from frozen section in theatre)
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Primary surgery in keeping with NICE guidelines in (lobectomy, either open or thoracoscopic), lung parenchymal-sparing operations (segmentectomy or wedge resection) if a complete resection can be achieved, extensive surgery (bronchoangioplastic surgery, bilobectomy, pneumonectomy) if necessary to obtain clear margins, hilar and mediastinal lymph node sampling or en bloc resection)
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Minimum tumour diameter at least 10mm to allow for sampling of at least two tumour regions (if 10mm, a high likelihood of nodal involvement on pre-operative imaging required to meet eligibility according to stage, i.e., T1 N1-3)
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Deemed to be fit for surgery
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Considered sufficiently fit for standard of care adjuvant therapy if indicated
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Performance status 0 to 1
Cohort B:
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Participants ≥18 years of age, with late-stage unresectable stage IIIB and above NSCLC disease (TNM 8th edition) or presenting with stage IV de novo metastatic disease.
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Sufficient tissue (at least 1 region/biopsy), either FFPE or fresh frozen
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Deemed to be fit for anti-cancer treatment
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Performance status 0 to 2
Cohort C:
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Participants ≥18 years of age, with any stage SCLC.
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Sufficient tissue (at least 1 region/biopsy), either FFPE or fresh frozen
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Deemed to be fit for anti-cancer treatment
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Performance status 0 to 2
Exclusion Criteria:
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Cohort A, B and C:
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Other active malignancy
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Any other* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy).
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Any other* current malignancy or malignancy diagnosed or relapsed within the past 3 years**.
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*Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer
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**An exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of NSCLC.
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Psychological condition that would preclude informed consent
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Diagnosis other than NSCLC or SCLC confirmed following surgery or biopsy
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History of intravenous drug abuse within the last 5 years
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Confirmed diagnosis of known high-risk infections (e.g., Human Immunodeficiency Virus) (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection, tuberculosis and Creutzfeldt-Jacob disease) unless participant case is of a particular scientific interest and agreed in advance with research staff, local mortuary staff and pathologist.
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Contra-indicated co-morbid conditions
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Women who are pregnant or breast feeding
Cohort A:
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Positive margins, incomplete resection or insufficient nodal sampling
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Participation in a neo-adjuvant or adjuvant therapeutic trial with non-standard of care therapy
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Insufficient tissue, i.e., a minimum of two tumour regions unlikely to be obtained for the study based on pre-operative imaging
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Participant found to have pre-invasive lesions rather than invasive cancer following surgery, such as adenocarcinoma in situ or minimally invasive lesions will be withdrawn. However, the surgical tissue and baseline blood already collected will be sent to the central laboratory. These participants will not be followed-up in the study or required to provide any further blood samples. If these participants subsequently develop invasive cancer, the date of diagnosis and the tumour histology will be reported on the electronic data capture system.
Cohort B/C:
• Insufficient tissue, i.e., at least one tissue biopsy to be obtained (Fresh Frozen or FFPE)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University College, London
- Cancer Research UK
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UCL - 151927