| Eligibility |
Inclusion Criteria:
- Cohort A, B and C :
- Written Informed consent
- Agreement to be followed up (including on-study assessments and sample
collection) every 3 months in the first 2 years and then 6 monthly.
- Agreement to be followed up at a TRACERx EVO site
Cohort A:
- Participants =18 years of age, with early stage I-IIIB NSCLC disease who are eligible
for primary surgery
- Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging
necessitating surgery (e.g., diagnosis determined from frozen section in theatre)
- 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)
- For participants proceeding with upfront primary surgery (i.e. no neoadjuvant
therapy), a minimum tumour diameter at least 15mm to allow for sampling of at least
two tumour regions
- Participants undergoing neoadjuvant treatment must have at least 1 region of fresh
frozen or FFPE surgical or diagnostic biopsy tissue.
- Considered sufficiently fit for upfront standard of care primary surgery or
neoadjuvant therapy if indicated
- Performance status 0 to 2
Cohort B:
- 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.
- Sufficient tissue (at least 1 region/biopsy), either FFPE or fresh frozen
- Deemed to be fit for anti-cancer treatment
- Performance status 0 to 2 Participants who were initially consented into Cohort A with
a post-surgical staging of stage IIIB/C or IV could be included in Cohort B.
Cohort C:
- Participants =18 years of age, with any stage SCLC or pleural mesothelioma.
- Sufficient tissue (at least 1 region/biopsy), either FFPE or fresh frozen
- Deemed to be fit for anti-cancer treatment
- Performance status 0 to 2
Exclusion Criteria:
- Cohort A, B and C:
- Other active malignancy
- Any other* malignancy diagnosed or relapsed at any time, which is currently being
treated (including by hormonal therapy).
- Any other* current malignancy or malignancy diagnosed or relapsed within the past
3 years**.
- *Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and
in situ cervical cancer
- **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.
- Psychological condition that would preclude informed consent
- Diagnosis other than NSCLC, SCLC or pleural mesothelioma confirmed following
surgery or biopsy
- 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.
- Contra-indicated co-morbid conditions
Cohort A:
- Positive margins, incomplete resection or insufficient nodal sampling
- Participation in a neo-adjuvant or adjuvant therapeutic trial with non-standard of
care therapy
- Insufficient tissue, i.e., for participants having upfront surgery and not having
neoadjuvant therapy, a minimum of two tumour regions unlikely to be obtained for the
study based on pre-operative imaging. For participants having neoadjuvant therapy
i.e., at least one tissue biopsy to be obtained (Fresh Frozen or FFPE).
- 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)
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