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Proseq Cancer: Genomic Profiling in Patients With Incurable Cancer in Search for Targeted Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05695638
Recruitment Status : Recruiting
First Posted : January 25, 2023
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Morten Ladekarl, Aalborg University Hospital

Brief Summary:

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
Solid Tumor, Unspecified, Adult Haematological Malignancy

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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
Intention-to-treat cohort
All patients included



Primary Outcome Measures :
  1. 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
For molecular profiling the tumor DNA is subjected to somatic short variant detection using tumor/normal WES analysis, detection of copy number alterations, TMB and MSI status, and mutational signature analysis. Tumor RNA is used for the generation of an expression profile. Moreover, RNAseq enables detection of fusion transcripts. ctDNA is extracted from 10 ml blood samples or peritoneal fluid. Sequencing is performed on a NovaSeq 6000. Clinically relevant pathogenic variants are detected in a small set of genes. Germline variants in other genes are not analyzed, unless specifically requested and consented by the patient. Raw sequencing data are processed and stored under the regional IT-system. Sequencing data and supplementary metadata are submitted to the Danish National Genome Center.


Information from the National Library of Medicine

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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 incurable, progressing and/or life-threatening cancer with an expected residual survival of at least 3 months and no efficient remaining standard treatment options. Patients are recruited from the Region of Northern Jutland, Denmark.
Criteria

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

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): NCT05695638


Contacts
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Contact: Morten Ladekarl, MD, DMSci +45 97660545 morten.ladekarl@rn.dk
Contact: Anja Pagh, MD, PhD +45 97661417 a.pagh@rn.dk

Locations
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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   
Sponsors and Collaborators
Morten Ladekarl
Investigators
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Principal Investigator: Morten Ladekarl, MD, DMSCi Department of Oncology, Aalborg University Hospital, Denmark
Publications:
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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

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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
Keywords provided by Morten Ladekarl, Aalborg University Hospital:
Precision medicine
Personalized medicine
Genomic profiling
Tissue agnostic
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases