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Trial record 1 of 1 for:    NCT04566614
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Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies (PREVAILctDNA)

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ClinicalTrials.gov Identifier: NCT04566614
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : February 22, 2023
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
The purpose of this study is to investigate the feasibility of using ctDNA to support cancer diagnosis and risk stratification where invasive aerosol generating testing (and/or tissue biopsy) is challenging due to infection risk, technical impracticalities and resource limitations, such as during the COVID-19 pandemic and the subsequent recovery period.

Condition or disease Intervention/treatment
Neoplasm, Colorectal Neoplasm of Lung Neoplasm, Bladder Neoplasms Pancreatic Biliary Tract Neoplasms Gastro Intestinal Stromal Tumour Other: ctDNA blood sampling

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Study Type : Observational
Estimated Enrollment : 294 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : December 31, 2025


Group/Cohort Intervention/treatment
Biliary Tract Cohort
Patients with suspected biliary tract cancer will be offered ctDNA to support a diagnosis in patients with suspected early stage, locally advanced and advanced disease. This includes patients with tumours that are technically challenging to access with invasive biopsy or due to limitations in endoscopic ultrasound due to the COVID-19 pandemic. Patients with histological diagnosis will not be eligible for this study. Patients with suspected cancer will have ctDNA result (positive or negative) discussed at MDT in conjunction with PREVAIL-imaging risk stratification pathway to risk stratify in terms of cancer risk (low, intermediate and high risk), serum tumour markers and patient presentation which will dictate the appropriate treatment. Those with metastatic disease will have their treatment decision based on ctDNA result, radiology and patient characteristics after discussion between the treating clinician and patient
Other: ctDNA blood sampling
Screening/baseline blood sample to be analysed for ctDNA

Bladder Cancer Cohort
Patients with suspected bladder cancer (localised and metastatic) will be offered ctDNA to support their diagnosis, in cases where cystoscopy and biopsy are difficult to obtain due to the COVID-19 pandemic. Patients with histological diagnosis will not be eligible for this study. A positive ctDNA result will be supportive of a diagnosis of bladder cancer, their treatment may be prioritised and decided based on this result in conjunction with radiological findings, patient presentation and after discussion between the treating physician and patient
Other: ctDNA blood sampling
Screening/baseline blood sample to be analysed for ctDNA

Pancreatic Cancer Cohort
Patients with suspected pancreatic cancer will be offered ctDNA to support a diagnosis in patients with suspected early stage, locally advanced and advanced disease. This includes patients with tumours that are technically challenging to access with invasive biopsy or due to limitations in endoscopic ultrasound due to the COVID-19 pandemic. Patients with histological diagnosis will not be eligible for this study. Patients with suspected cancer will have ctDNA result (positive or negative) discussed at MDT in conjunction with PREVAIL-imaging risk stratification pathway to risk stratify in terms of cancer risk (low, intermediate and high risk), serum tumour markers and patient presentation which will dictate the appropriate treatment. Those with metastatic disease will have their treatment decision based on ctDNA result, radiology and patient characteristics after discussion between the treating clinician and patient
Other: ctDNA blood sampling
Screening/baseline blood sample to be analysed for ctDNA

Gastrointestinal Stromal Tumour Cohort
Those with suspected Gastrointestinal Stromal Tumour Cohort (GIST) are eligible for this study. KIT and PDGFR mutation detected using ctDNA in conjunction with radiological features will be supportive of a diagnosis of GIST. This may allow for the use of directed targeted therapy, or prioritise surgical resection in some cases. Patients with histological diagnosis will not be eligible for this study. However, patients with inadequate tissue for KIT/PDGFR analysis will be eligible for PREVAIL-ctDNA to confirm the diagnosis of GIST and help guide treatment decisions
Other: ctDNA blood sampling
Screening/baseline blood sample to be analysed for ctDNA

Lung Cancer Cohort
The use of ctDNA in the diagnosis and adaptive management of patients with lung cancer is well established, however not funded by NHS. As aerosol-generating bronchoscopy procedures have reduced due to the COVID-19 pandemic, patients with suspected lung cancer may be offered ctDNA to support the diagnosis. A positive ctDNA result in conjunction with radiological findings will assist in prioritising those suitable for upfront surgical resection, radiotherapy or systemic anti-cancer treatment. It may provide sufficient genotypic information to guide standard of care targeted therapies (usually two tests are required - biopsy and then next generation sequencing of extracted DNA), including in patients without sufficient tissue for EGFR and ALK testing which can be detected using ctDNA. The use of ctDNA to guide treatment decisions in this cohort will not require signed consent as it is considered a standard approach (not yet NHS funded)
Other: ctDNA blood sampling
Screening/baseline blood sample to be analysed for ctDNA

Colorectal Cancer Cohort
Patients with suspected colorectal cancer will often be referred following either suspicion on imaging or faecal immunochemical testing (FIT). FIT testing results will be used to prioritise patients for screening colonoscopy, in conjunction with the PREVAIL-imaging risk stratification pathway
Other: ctDNA blood sampling
Screening/baseline blood sample to be analysed for ctDNA

Part 2 Cohort
Patients with suspected advanced pancreatic or biliary tract cancer who have ctDNA via the ACCESS implementation pathway. The results must be deemed consistent with or diagnostic of pancreatic/biliary tract cancer by the molecular tumour board, discussed at central MDT and the patient cannot have a histological diagnosis.



Primary Outcome Measures :
  1. ctDNA detection rate within different cancer types (and overall) [ Time Frame: Throughout study completion, up to one year ]
    The primary endpoint, ctDNA detection rate, overall and within different cancer types will be presented as a proportion of patients with a positive ctDNA test out of those tested, with 90% confidence intervals

  2. PREVAIL ctDNA Part 2 Study [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Primary end point, Proportion of patients with detectable ctDNA which supports a diagnosis of malignancy and commence treatment


Secondary Outcome Measures :
  1. Proportion of patients with a positive ctDNA result which identified a diagnosis and/or commenced treatment [ Time Frame: Throughout study completion, up to one year ]
    All secondary endpoints will be analysed in the patients diagnosed with suspected cancer, i.e. positive ctDNA result, unless stated. They will also be presented overall and by cancer type. The proportion of patients with positive ctDNA result which identified a diagnosis and/or commenced treatment will be presented as a proportion with 90% confidence intervals

  2. Proportion of patients with a positive ctDNA result which assisted in prioritising invasive diagnostic tests [ Time Frame: Throughout study completion, up to one year ]
    Proportion of patients with positive ctDNA result which assisted in prioritising invasive diagnostic tests will be presented as a proportion with 90% confidence intervals

  3. The association of ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result [ Time Frame: Throughout study completion, up to one year ]
    The association between ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result will be assessed descriptively by presenting cross-tabulations and relevant proportions

  4. Estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation [ Time Frame: Throughout study completion, up to one year ]
    Simple estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation will be performed

  5. PREVAIL ctDNA Part 2 Study secondary end point 1a [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Treatment response objective response rate

  6. PREVAIL ctDNA Part 2 Study secondary end point 1b [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Progression free survival

  7. PREVAIL ctDNA Part 2 Study secondary end point 1c [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Overall survival

  8. PREVAIL ctDNA Part 2 Study secondary end point 2 [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Proportion of patients who undergo a repeated invasive procedure

  9. PREVAIL ctDNA Part 2 Study secondary end point 3a- comparison with NHS targets [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Comparison of diagnostic pathway duration with NHS faster Diagnostic Standard (FDS)

  10. PREVAIL ctDNA Part 2 Study secondary end point 3b- comparison with NHS targets [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Comparison of diagnostic pathway duration with 62 day wait target

  11. PREVAIL ctDNA Part 2 Study secondary end point 4a [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Type of complications from invasive diagnostic procedures

  12. PREVAIL ctDNA Part 2 Study secondary end point 4b [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Frequency of complications from invasive diagnostic procedures

  13. PREVAIL ctDNA Part 2 Study secondary end point 4c [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Severity of complications from invasive diagnostic procedures

  14. PREVAIL ctDNA Part 2 Study secondary end point 5 [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Number and type of invasive procedures performed

  15. PREVAIL ctDNA Part 2 Study secondary end point 5b [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Number of histopathology reviews

  16. PREVAIL ctDNA Part 2 Study secondary end point 5c [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Number of tissue based NGS performed

  17. PREVAIL ctDNA Part 2 Study secondary end point 6a [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Healthcare costs associated with diagnostic pathway

  18. PREVAIL ctDNA Part 2 Study secondary end point 6b [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Cost per-quality adjusted-life-year of diagnostic pathway

  19. PREVAIL ctDNA Part 2 Study secondary end point 6c [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Number of hospital visits in diagnostic pathway

  20. PREVAIL ctDNA Part 2 Study secondary end point 6d [ Time Frame: To run parallel for 12 months alongside the ACCESS implementation programme ]
    Length of hospital stay during diagnostic pathway



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected malignancy for whom invasive biopsy for definitive histological diagnosis is challenging either due to COVID-19-related resource limitations, infection control or technical feasibility will be considered for this study
Criteria

Inclusion Criteria:

  • Participants aged ≥18 years old
  • Patients with suspected malignancies of early stage colorectal cancer (FIT intermediate and high risk), early and late stage pancreatic cancer, biliary tract cancer, gastro-intestinal stromal tumours, lung cancer or bladder cancer, without a definitive histological diagnosis (including those with inconclusive biopsy result) or
  • Patients with histological diagnosis of lung cancer without adequate tissue for NHS genomic test directory predictive biomarker testing
  • Ability to provide informed consent.
  • Patients with performance status suitable for oncological treatments (ECOG performance status 0-2).

Exclusion criterion:

• Patients with an established histological diagnosis adequate to support standard of care treatment

PART 2:

Inclusion criteria

  • Included in the ACCESS implementation programme
  • Has detectable ctDNA on Guardant360© assay
  • Discussion at molecular tumour board and central multi-disciplinary meeting confirming ctDNA variant is supportive of diagnosis of PC/BTC (diagnostic or consistent with)
  • Performance status suitable for oncological treatment
  • Ability to provide informed consent

Exclusion criteria

  1. Previously diagnosed invasive or haematological malignancy within the past 3 years
  2. Outcome at the molecular tumour board not supportive of cancer diagnosis (possibly consistent or not consistent)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566614


Contacts
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Contact: Naureen Starling, MBBS MRCP MD 0208664778 Naureen.Starling@rmh.nhs.uk
Contact: Richard Crux, CIBiol 02086426011 Richard.Crux@rmh.nhs.uk

Locations
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United Kingdom
Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Naureen Starling    +44 020 7352 8171    naureen.starling@rmh.nhs.uk   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Justin Mencel, MBBS Royal Marsden Hospital NHS Foundation Trust
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04566614    
Other Study ID Numbers: CCR 5292
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: February 22, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Biliary Tract Neoplasms
Lung Neoplasms
Colorectal Neoplasms
Gastrointestinal Stromal Tumors
Urinary Bladder Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases