Hepatic Malignant Neoplasm Primary Non-ResectableNCT03266042
Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy
An observational study of Hepatic Malignant Neoplasm Primary Non-Resectable, run by Delcath Systems Inc. at 2 sites in United Kingdom.
Trial summary
Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatic Malignant Neoplasm Primary Non-Resectable
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Jan 2016to Feb 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received or will receive treatment with CHEMOSAT for the Treatment of Unresectable Hepatic Malignancy
- Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT.
- Have provided written informed consent according to institutional and regulatory guidelines
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Southampton University Hospitals and University of Southampton
Southampton
Ioannis Karydis, Dr.
- Recruiting
Spire Southampton Hospital
Southampton
Sanjay Gupta, Dr.
About this study
Official title: Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP With the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
Read the detailed description
Post Marketing study:
The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2012. This registry study is designed to collect safety, resource utilization and treatment outcomes in patients who receive this treatment with CHEMOSAT by healthcare professionals. The safety and efficacy data from patients treated with CHEMOSAT is important in updating the safety profile and for collection of treatment information. The resource utilization information is essential in planning treatment strategy for patients.
This registry does not follow any pre-determined protocol with respect to diagnosis, treatment or follow-up of the patient. The data collected will be gathered exclusively from current medical practice at participating institutions.
Delcath holds a list of authorized customer hospitals to whom it supplies the CHEMOSAT System. To date these hospitals have treated over 300 patients with cancers of the liver.
The decision to treat with CHEMOSAT is clearly separated from the decision to collect data in the registry. No specific procedures or tests are required in this protocol.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).
Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge
Measured: Post-procedure (up to 30 days after CS-PHP)
Secondary outcomes (4)
Percentage of treatment with CHEMOSAT each patient receives
The percentage of treatments with CHEMOSAT each patient receives based on primary tumor
Measured: From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]
Evaluation of Best Overall Response
Evaluation of patient best overall response (partial response or complete response, when applicable)
Measured: from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]
Evaluation of resource utilization
Percentage of days spent in ICU, step-down area
Measured: From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months]
Evaluate time to treatment failure
Time of first CHEMOSAT treatment to time of treatment failure
Measured: time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start14 Jan 2016
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Malignant Neoplasm Primary Non-ResectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Delcath Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266042
- Sponsor's protocol ID
- PHP-M-REG01
- Status last verified
- Sep 2018
- First submitted
- 22 Aug 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP With the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
- ClinicalTrials.gov ID
- NCT03266042
- Acronym / sponsor ID
- PHP-M-REG01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Delcath Systems Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy
Detailed description
Post Marketing study:
The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2012. This registry study is designed to collect safety, resource utilization and treatment outcomes in patients who receive this treatment with CHEMOSAT by healthcare professionals. The safety and efficacy data from patients treated with CHEMOSAT is important in updating the safety profile and for collection of treatment information. The resource utilization information is essential in planning treatment strategy for patients.
This registry does not follow any pre-determined protocol with respect to diagnosis, treatment or follow-up of the patient. The data collected will be gathered exclusively from current medical practice at participating institutions.
Delcath holds a list of authorized customer hospitals to whom it supplies the CHEMOSAT System. To date these hospitals have treated over 300 patients with cancers of the liver.
The decision to treat with CHEMOSAT is clearly separated from the decision to collect data in the registry. No specific procedures or tests are required in this protocol.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received or will receive treatment with CHEMOSAT for the Treatment of Unresectable Hepatic Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter).
Time frame: Post-procedure (up to 30 days after CS-PHP)
Data to be collected at: Baseline, treatment and post treatment laboratory values and clinical measurements until time of discharge
4 secondary outcomes
Percentage of treatment with CHEMOSAT each patient receives
Time frame: From the first CHEMOSAT treatment through the last, [timeframe an average of 12-months if 6 cycles completed]
Evaluation of Best Overall Response
Time frame: from the date of first CHEMOSAT treatment through last CHEMOSAT treatment, or treatment discontinuation or death (whichever occurs first) [assessed up to 24 months]
Evaluation of resource utilization
Time frame: From the first CHEMOSAT treatment through the last CHEMOSAT treatment [assessed up to 24 months]
Evaluate time to treatment failure
Time frame: time from first CHEMOSAT treatment to the date of last CHEMOSAT treatment [assesed up to 24 months]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Malignant Neoplasm Primary Non-Resectable, run by Delcath Systems Inc. at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie Callahan, BSN, MS (212-489-2100 ext. 247, lcallahan@delcath.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gather key safety data on the use of CHEMOSAT Kit (Gen 2 filter). (time frame: Post-procedure (up to 30 days after CS-PHP)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2018.