2148 MRD

PROJECT DESCRIPTION

Solid tumours account for most cancer-related deaths in adults, mainly in metastatic settings. However, nearly two-thirds of patients are diagnosed at the loco-regional stage when treatments with curative intent are possible. For these patients, early detection of relapse after curative treatment might provide an opportunity for additional salvage therapy. The concept of Minimal Residual Disease (MRD) aims to identify small numbers of tumour cells persisting after radical treatment in a non-invasive manner, such as through liquid biopsy. This project focuses on assessing the potential of circulating tumour DNA (ctDNA) as a surrogate marker for recurrence. 

Benjamin Besse Jean-Pascal Machiels
(H&N)		 Marc Oliva
(H&N)		 Rebecca Lee
(Melanoma)		 Paul Lorigan
(Melanoma)

This is a longitudinal study involving regular blood draws for ctDNA analysis in patients with solid tumours who are disease-free after radical treatment. The study will follow patients for up to two years or until recurrence. A free molecular report will be generated for the patients enrolled1,2, containing relevant molecular alterations. Molecular Tumour Boards will discuss the  alterations and provide recommendations2.

1: when sufficient tumour material is provided
2: Molecular reports and recommendations are for research use only

Patients eligible for this study are those diagnosed with a solid tumour and treated in a curative setting, with a high risk of relapse (around 50% within two years). They must be disease-free, confirmed by negative imaging at the baseline timepoint after radical treatment, and clinically followed up according to ESMO guidelines. The minimum age for enrolment is 12 years.

List of cohort

At enrolment, FFPE material and blood samples for ctDNA and/or gDNA, will be mandatory, depending on the specifications for each cohort.
At every patient visit, when planned as per standard of care, a blood draw (up to 40mL) will be performed.

The 2148 MRD is supported by Guardant Health and La ligue contre le cancer

LIST OF COHORTS

For SPECTA, please enroll patients with the tumor type specified in the table, ONLY when the status is green. You can enroll those patients by clicking on the , next to the green status.
Study specific information (HBM, Project Specific selection criteria, CRF completion guidelines…) can be found here . Please note that your electronic database ORTA password is required for access (protocol 1553).

For any questions, please contact the project address: 2148@eortc.org.

To view the List of Cohorts, please flip your mobile phone horizontally:

Primary disease Status
  • Patients with newly diagnosed Stage III, IVA, or IVB squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx and cervical primary unknown.
  • To be treated with curative intent with either radiation, concomitant chemo-radiation, cetuximab plus radiation, or surgery with or without post-operative (chemo)radiation.
 Open to activated sites

Primary disease Status    
  •  Patients must have a histologically confirmed diagnosis of cutaneous melanoma.
  • Eligibility depends on the timing of inclusion in relation to surgery:
    • For patients included after surgery: Patients must have Stage IIIC or IIID, as determined by sentinel lymph node staging, in accordance with the AJCC 8th edition and should enter the study not later than 3-4 months after the surgery (at the time of baseline imaging post-surgery), and prior to starting adjuvant treatment.
    • For patients included prior to surgery: Patients must have T4b disease (i.e., Breslow thickness >4.0 mm with ulceration), or clinically detectable disease.
  • To be treated with curative intent with:
    • Complete lymph node dissection (CLND) if indicated, or sentinel lymph node biopsy (SNLB) +/- adjuvant therapy (either anti-PD-1 or dabrafenib plus trametinib).
    • Neoadjuvant therapy followed by surgery and adjuvant therapy (anti-PD-1).
 In activation