UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061237 |
|---|---|
| Receipt number | R000070070 |
| Scientific Title | A two-center prospective observational cohort study comparing 14-day treatment continuity of PICC versus subcutaneous route in hospitalized cancer patients receiving palliative care |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/11 15:17:38 |
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Basic information
Public title
A two-center prospective observational study of treatment continuity with PICC versus subcutaneous route in hospitalized cancer patients receiving palliative care
Acronym
PICC-SC study
Scientific Title
A two-center prospective observational cohort study comparing 14-day treatment continuity of PICC versus subcutaneous route in hospitalized cancer patients receiving palliative care
Scientific Title:Acronym
PICC-SC study
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare 14-day treatment continuity in real-world practice between peripherally inserted central catheter (PICC) and subcutaneous route (SC) selected as the main route of administration in hospitalized cancer patients who required an additional route because peripheral venous access was difficult or expected to become difficult.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment continuity over 14 days. This is defined as maintenance of the selected main route from Day 0 (the day SC or PICC started as the main route) through Day 14 without access-related failure.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cancer patients aged 18 years or older receiving palliative care.
Patients judged clinically to have difficulty in securing peripheral venous access, or expected to have such difficulty in the near future, and requiring continuation of injectable treatment.
Patients for whom either PICC or the subcutaneous route (SC) is considered a clinically appropriate option, and whose attending physician selected one of these routes (initiation of SC or PICC order/insertion).
The presence or absence of an implanted port is not restricted; however, only patients in whom the attending physician judged that the port alone was insufficient to continue the main injectable treatment of interest, or that an additional route was clinically necessary, and who were newly selected for PICC or SC, are eligible.
Key exclusion criteria
Patients in whom stable injectable treatment can be continued via peripheral venous access and for whom PICC or SC is not clinically considered.
Patients with a PICC already inserted by another department or service and already being continuously used as the main route for injectable treatment at the time of study allocation.
Patients with an absolute contraindication to PICC insertion, such as obvious infection at the planned insertion site, known deep vein thrombosis of the intended upper extremity or severe venous obstruction, uncontrolled major bleeding risk, or explicit patient refusal.
Patients who expressed refusal to participate in the study through the opt-out process.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kawabata |
Organization
Osaka Rosai Hospital
Division name
Department of Palliative Care
Zip code
5918025
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
TEL
072-252-3561
off.kawabata@gmail.com
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kawabata |
Organization
Osaka Rosai Hospital
Division name
Department of Palliative Care
Zip code
5918025
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
TEL
072-252-3561
Homepage URL
off.kawabata@gmail.com
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Rosai Hospital
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
Tel
072-252-3561
somuk-osakah@m.johas.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a two-center prospective observational cohort study. Eligible participants are hospitalized cancer patients who require a newly selected main administration route because peripheral venous access is difficult or expected to become difficult, and who start either PICC or the subcutaneous route (SC) as the main route. The exposure of interest is the selected main route (PICC or SC), and the primary outcome is treatment continuity from Day 0 through Day 14. No allocation is performed; route selection is left to treating physicians under routine clinical practice at each center. Consecutive case enrollment will be used. For analysis, propensity score-based confounding adjustment will be applied, with assessment of center effect and overlap, and methods accounting for death as a competing event.
Management information
Registered date
| 2026 | Year | 04 | Month | 12 | Day |
Last modified on
| 2026 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070070
