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Urothelial CarcinomaPhase 4VitDURONCT04197089

Biological Effect of Vitamin D in Patients With Urothelial Carcinoma

A Phase 4 study testing Vitamin D in people with Urothelial Carcinoma, run by Germans Trias i Pujol Hospital at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study population will be 50 women or men diagnosed with urothelial cancer candidates to undergo cystectomy as part of their antitumor treatment. The main objective of the study is to determine the biological effect of Vitamin D on tumor tissue phenotype; for thus, all subjects enrolled in the study will take… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Vitamin D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteSpain
Study dates
11 Feb 2020to 22 Nov 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women older than 18 years
  • Patients willing and able to read and understand the patient's information sheet and give their consent
  • Histologically confirmed diagnosis of urothelial non-muscle-invasive bladder cancer (T1 high grade and/or carcinoma in situ), and patients with muscle-invasive or high urinary tract carcinoma without evidence of distant metastasis (T2-4N0M0)
  • Candidate patients to undergo treatment by radical cystectomy or nephroureterectomy as part of conventional tumor treatment.
  • Not having received any antitumor treatment during the 4 weeks prior the administration of Vitamin D
  • Life expectancy longer than 6 months
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  • Karnofsky Index > 70%
  • Confirmed adequate bone marrow, kidney and liver functions by:
  • Leukocyte count > 4.000
  • Platelet count > 100.000
  • Haemoglobin levels > 10 gr/dl
  • Serum bilirubin levels < 1,5X the upper limit of normality
  • AST and ALT levels < 2,5X the upper limit of normality
  • Alkaline Phosphatase levels < 5X the upper limit of normality
  • Serum creatinine levels ≤ 2 mg/dl, and/or GFR ≥ ml/min/1.73m2 estimated by MDRD-4 IDMS or CKD-EPI evaluation
  • Plasma calcium levels between 8.8 and 10.6 mg/dl, and 24 hours urine calcium levels between 100 and 300 mg/24h
  • Women of childbearing potential should use a highly effective contraceptive method according the Clinical Trial Facilitation Group (such as combined hormonal contraceptives or IUD), and should continue its use for 90 days after the last dose of Vitamin D
  • Males in fertile age, with potentially fertile partner, should use a contraceptive method such as sexual abstinence or barrier method (condom), throughout the clinical trial and up to 90 days after the end of treatment, or be vasectomized

Who cannot join

  • Ade older than 80 years
  • Patients with non-urothelial histology. Those with mixed histology may be included if the urothelial component is the predominant (> 50%)
  • Administration of neoadjuvant chemotherapy
  • Administration of radiotherapy during the period between TUR and surgery
  • Medical history of another neoplasm diagnosed in the previous 3 years (except carcinoma in situ or non-melanoma cutaneous carcinoma). It may be included those patients with history of other neoplasms, provided that after receiving radical treatment do not relapsed
  • History of hypersensitivity to Vitamin D
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  • History of renal lithiasis larger than 5 mm or symptomatic in the year prior its inclusion in the study, and/or nephrocalcinosis
  • History of hypercalcemia and/or hypercalciuria
  • Situation of hypervitaminosis (25-OH Vitamin D > 50 ng/ml)
  • Previous treatment with Vitamin D in the last 6 months
  • Chronic treatment with corticosteroids
  • Other serious diseases or medical processes such as: infection that requires systemic anti-infective treatment or not controlled serious medical processes, including severe heart disease (episodes of ischemic heart disease in the last 6 months, cardiac arrhythmia or heart failure)
  • Medical history of sarcoidosis or parathyroid disease
  • History of malabsorption syndrome (for example pancreatic insufficiency, celiac disease or Crohn's disease), history of small bowled resection or any medical condition that may interfere with Vitamin D absorption
  • Patients who are expected to administer nutritional supplements containing Vitamin D, or who are being treated with drugs (or combination of drugs) that contain Vitamin D
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

Other trials in Spain

About this study

Official title: Pilot Study of the Biological Effects of Vitamin D in Patients With Resectable Urinary Tract Urothelial Carcinoma

The study population will be 50 women or men diagnosed with urothelial cancer candidates to undergo cystectomy as part of their antitumor treatment. The main objective of the study is to determine the biological effect of Vitamin D on tumor tissue phenotype; for thus, all subjects enrolled in the study will take Vitamin D supplementation 4 weeks prior undergoing surgery. Urothelial tissue will be obtained from the surgical procedure and will be studied for the Vitamin D effect on cancer cell, compared with that urothelial tissue biopsy obtained in the moment of cancer diagnosis.

Read the detailed description

The study will enroll 50 patients (older than 18 and younger than 80 years old), recently diagnosed with urothelial cancer and candidates to undergo radical cystectomy or nephroureterectomy.

At the baseline visit, a blood sample will be obtained for 25OH-VitD analysis and all subjects will receive first dose of 10.000 IU Vitamin D. Depending of basal plasmatic Vitamin D value, patients will be stratified in either 10.000 IU treatment (25OH-VitD ≥ 20 ng/ml) or either 50.000 UI treatment dose (25OH-VitD < 20 ng/ml). Treatment will consist of 4 doses taken weekly before their scheduled cystectomy. Last study follow-up visit will be 4 weeks post-surgery. Urothelial tumor tissue collected on surgery will be used to evaluate the expression of tumor differentiation and Vitamin D markers, using genomics and proteomics approaches. Blood sample will also be collect throughout the study to evaluate the pharmacokinetics of Vitamin D in plasma and the expression of Vitamin D target genes in peripheral blood leukocytes.

Being tested
Vitamin D
Keywords
Cancer, Urinary tract, Cystectomy, Vitamin D, Tissue phenotype
Medical subject headings
Carcinoma, Transitional Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDrug

    Also called Cholecalciferol, Colecalciferol

    First dose of 10.000 IU Vitamin D at baseline visit for all patients; stratification of treatment (10.000 or 50.000 IU Vitamin D) depending base 25(OH)Vitamin D levels. Treatment weekly during 4 weeks before scheduled cystectomy

Study groups in NCT04197089
Study groupRoleWhat they receive
Vitamin D treatmentExperimentalTreatment with 10.000 IU or 50.000 IU Vitamin D weekly during 4 weeks
Receives: Drug: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analysis of gene expression in urothelial tumor tissue, comparing initial tumor biopsy and cystectomy tumor tissue exposed to Vitamin D (reported in number of mRNA copies)

    Measurement of mRNA levels of differentiation and Vitamin D response markers (FGFR3, CDH1, CDKN1A/p21, THBD, VDR, G0S2 and GAPDH), determined by quantitative reverse transcription PCR (RT-qPCR)

    Measured: One year post-cystectomy

  2. Analysis of protein expression in urothelial tumor tissue, comparing initial tumor biopsy and cystectomy tumor tissue exposed to Vitamin D (reported in arbitrary units)

    Measurement of expression and distribution of differentiation and Vitamin D response markers (FGFR3, CDH1, CDH2, VDR, Ki67, CDKN1A/p21, KRT5, KRT14, KRT20 and UPK), determined by immunohistochemistry (IHC)

    Measured: One year post-cystectomy

Secondary outcomes (2)

  1. Analysis of gene expression in peripheral blood leukocytes (reported in number of mRNA copies)

    Changes in the expression of Vitamin D target genes (CD14, CAMP, THBD and GAPDH) of peripheral leukocytes, determined by quantitative reverse transcription PCR (RT-qPCR)

    Measured: One to five months post-cystectomy

  2. Levels of serum 25(OH)Vitamin D (reported in ng/ml)

    Determination of serum 25(OH)Vitamin D for pharmacokinetics study. First Vitamin D level will be obtained at screening visit and last Vitamin D level at the end of the study 4 weeks post-cystectomy

    Measured: Ten weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2019
  2. Study start11 Feb 2020
  3. Primary completion22 Nov 2021
  4. Study completion22 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Treatment stratified with 10.000 IU or 50.000 IU Vitamin D depending of baseline 25(OH)Vitamin D plasmatic levels
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04197089
Sponsor's protocol ID
VitDURO-AECC17-01
Acronym
VitDURO
Status last verified
Aug 2022
First submitted
3 Dec 2019
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D in people with Urothelial Carcinoma, run by Germans Trias i Pujol Hospital at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of gene expression in urothelial tumor tissue, comparing initial tumor biopsy and cystectomy tumor tissue exposed to Vitamin D (reported in number of mRNA copies) (time frame: One year post-cystectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04197089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.

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