Malignancies in Transplanted Patients

Neoplasms Clinical Trial

— MALTX  

Official title:

Follow-up of Malignancies in Transplanted Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241564
• Other study ID #: MALTX-001
• Status: Completed
• Phase: N/A
• First received: September 11, 2014
• Last updated: October 24, 2017
• Start date: November 2007
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients willing and capable of giving written informed consent of participation in the project

• Patients with a previous diagnosed or presently diagnosed or reoccurrence of a malignancy (other then basal cell carcinoma)

Exclusion Criteria:

• Patients with a primary liver cancer as cause of the transplantation

Related Conditions & MeSH terms

• Neoplasms

Intervention

Other:
• Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection

Drug:
• Switch from calcineurin inhibitor to an mTOR inhibitor

Locations

Country	Name	City	State
Sweden	Department of Surgery, Section of Transplantation Surgery, Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Hellström V, Lorant T, Döhler B, Tufveson G, Enblad G. High Posttransplant Cancer Incidence in Renal Transplanted Patients With Pretransplant Cancer. Transplantation. 2017 Jun;101(6):1295-1302. doi: 10.1097/TP.0000000000001225. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survival	After inclusion	12 months, 2 years, 3 years
Secondary	Graft survival	After inclusion	12 months, 2 years, 3 years
Secondary	ImmuKnow Assay value		12 months
Secondary	Tumour progression/regression/reoccurrence		12 months, 2 years, 3 years
Secondary	Maintained switch of immunosuppression from calcineurin inhibitor to mTOR inhibitor		3 years
Secondary	Kidney function	Creatinine measure	12 months, 2 years, 3 years