Proseq Cancer: Genomic Profiling in Patients With Incurable Cancer in Search for Targeted Treatment
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ClinicalTrials.gov Identifier: NCT05695638 |
Recruitment Status :
Recruiting
First Posted : January 25, 2023
Last Update Posted : January 31, 2024
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Proseq Cancer is a precision medicine program based on in-house whole exome sequencing (WES) and RNA sequencing. The approved protocol allows for biobanking, registration of clinical and laboratory data, and sharing of genomic data with the purpose of research, while fulfilling the Danish General Data Protection Regulation (GDPR) requirements. Patients are recruited from the North Denmark Region.
Treatment can be offered on site if a targeted drug of a nationally approved indication is suggested by the national tumor board (NTB). If not, the patient may be treated in an available clinical protocol. If no approved drug or relevant protocol is available or feasible, treatment with a targeted drug used outside a clinical protocol is pursued.
Condition or disease |
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Solid Tumor, Unspecified, Adult Haematological Malignancy |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 3000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 5 Years |
Official Title: | Proseq Cancer: A Prospective Study of Comprehensive Genomic Profiling in Patients With Incurable Cancer in Search for Targeted Treatment |
Actual Study Start Date : | July 1, 2020 |
Estimated Primary Completion Date : | May 31, 2030 |
Estimated Study Completion Date : | May 31, 2035 |
Group/Cohort |
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Intention-to-treat cohort
All patients included
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- The fraction (in %) of patients having a tumor molecular profiling done, for whom a molecularly "druggable" variant can be identified [ Time Frame: 10 years ]Total number of patients included for whom a molecular variant can be identified that potentially can be matched with a targeted drug, labelled for use in cancer, divided by total number of patients included having a tumor molecular profiling done.
Biospecimen Retention: Samples With DNA
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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 |
Inclusion Criteria:
- Incurable, progressing and/or life-threatening cancer
- Expected residual survival of at least 3 months
- No efficient remaining standard treatment options
- Patient recruited from the Region of Northern Jutland, Denmark
Exclusion Criteria:
- WHO Performance Status >2
- Significant comorbidity, concurrent medication or laboratory values imposing an unacceptable risk at medical oncological treatment
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): NCT05695638
Contact: Morten Ladekarl, MD, DMSci | +45 97660545 | morten.ladekarl@rn.dk | |
Contact: Anja Pagh, MD, PhD | +45 97661417 | a.pagh@rn.dk |
Denmark | |
Department of Oncology, Aalborg University Hospital | Recruiting |
Aalborg, Denmark, 9000 | |
Contact: Morten Ladekarl, MD, DMSci +45 97660545 morten.ladekarl@rn.dk | |
Contact: Anja Pagh, MD, PhD +45 97661417 a.pagh@rn.dk |
Principal Investigator: | Morten Ladekarl, MD, DMSCi | Department of Oncology, Aalborg University Hospital, Denmark |
Responsible Party: | Morten Ladekarl, Professor, Aalborg University Hospital |
ClinicalTrials.gov Identifier: | NCT05695638 |
Other Study ID Numbers: |
N-20200018 |
First Posted: | January 25, 2023 Key Record Dates |
Last Update Posted: | January 31, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Precision medicine Personalized medicine Genomic profiling Tissue agnostic |
Hematologic Neoplasms Neoplasms Neoplasms by Site Hematologic Diseases |