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

NCT05695638 | Recruiting

• 1 other identifier: N-20200018
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor, Unspecified, Adult; Haematological Malignancy

Keywords

Precision medicine; Personalized medicine; Genomic profiling; Tissue agnostic

Outcome Measures

Primary Outcomes (1)

• The fraction (in %) of patients having a tumor molecular profiling done, for whom a molecularly "druggable" variant can be identified

  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.

  10 years

Study Arms (1)

Intention-to-treat cohort

All patients included

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• WHO Performance Status \>2
• Significant comorbidity, concurrent medication or laboratory values imposing an unacceptable risk at medical oncological treatment

Sponsors & Collaborators

• Morten Ladekarl: lead

Study Sites (1)

Department of Oncology, Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Publications (2)

• Ladekarl M, Nohr AK, Sonderkaer M, Dahl SC, Sunde L, Vestereghem C, Mapendano CK, Haslund CA, Pagh A, Carus A, Lorincz T, Nowicka-Matus K, Poulsen LO, Laursen RJ, Dybkaer K, Poulsen BK, Frokjaer JB, Brugmann AH, Ernst A, Wanders A, Bogsted M, Pedersen IS. Feasibility and early clinical impact of precision medicine for late-stage cancer patients in a regional public academic hospital. Acta Oncol. 2023 Mar;62(3):261-271. doi: 10.1080/0284186X.2023.2185542. Epub 2023 Mar 11.

  PMID: 36905645 BACKGROUND

• Jakobsen MZ, Torp EA, Issa II, Hoholt H, Sonderkaer M, Madsen J, Christensen LM, Jorgensen MP, Nohr AK, Brondum RF, Kristensen DT, Dybkaer K, Severinsen MT, Due H. Evaluation of reference sample type for somatic variant calling in myeloid cancers. Ann Hematol. 2025 Nov;104(11):6091-6095. doi: 10.1007/s00277-025-06699-y. Epub 2025 Oct 22.

  PMID: 41123648 DERIVED

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.

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Morten Ladekarl, MD, DMSCi

  Department of Oncology, Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Ladekarl, MD, DMSci

CONTACT

+45 97660545; morten.ladekarl@rn.dk

Anja Pagh, MD, PhD

CONTACT

+45 97661417; a.pagh@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 25, 2023
• Study Start: July 1, 2020
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2035
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)