NCT02398890

Brief Summary

"Purpose: The overall prognosis of oncology patients admitted to intensive care has improved greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality in intensive care, more and more patients returning oncological circuit for the continuation of treatment of the underlying disease The existence of sequelae after the ICU (Intensive Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution without tumor progression. However, no studies have evaluated the effects of resuscitation on subsequent cancer treatment strategies. It would thus become better appreciate the long-term oncology patients discharged alive from the hospital after a stay in intensive care. Main purpose of research : Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors, after an intensive care stay for other reason than elective surgery monitoring or securing an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by the treating oncologist and classified total, partial or absent from that defined before or during the ICU stay Secondary objective of the research : Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital. Evaluate survival, lifestyle and physical and psychological effects of these patients after discharge from the hospital over a period of one year. It is understood that all these secondary endpoints will interfere with the existence of an evolutionary neoplasia not only with the ICU stay. They will therefore be interpreted with caution. Study Type: observational Study Design: Prognostic study of routine care, national, prospective, cohort type "

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2018

Enrollment Period

2.9 years

First QC Date

December 19, 2014

Last Update Submit

January 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with cancer admitted in ICU who will be eligible for optimal anti-cancer treatment after discharge from ICU

    Months12

Interventions

routine care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients with active solid tumor out alive from the ICU and monitoring in oncology in the same hospital as the resuscitator investigator.

You may qualify if:

  • Patient with progressive solid tumor hospitalized in intensive care and got out alive
  • Oncology patients followed in the same hospital as the investigator resuscitator
  • Age ≥ 18 years
  • Affiliate of social insurance
  • Agree to participate

You may not qualify if:

  • Patient hospitalized for programed surgery
  • Hospitalization for securing procedure
  • Pregnancy or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHI Le Raincy-Montfermeil

Montfermeil, 93370, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

March 26, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 17, 2019

Last Updated

January 13, 2021

Record last verified: 2018-01

Locations