Pancreatic CancerADL_DPC_PANCT06079229
Quality of Life in Elderly Patients After Pancreatic Cancer Surgery
An observational study of Pancreatic Cancer and Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. In France, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pancreatic Cancer, Surgery, Elderly
- What is being tested?
- Phone call
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2023to 24 Apr 2024
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study focuses on adult patients over the age of 70 with pancreatic cancer (of any type) who have undergone pancreatectomy and have been operated on at the Édouard Herriot Hospital, Lyon, France since July 2021.
Who may be able to join
- Subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen
- Operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the Édouard Herriot Hospital since July 2021
- 70 years of age or older at the time of surgery.
Who cannot join
- Patients who have expressed their opposition to the study
- Patients under curatorship, guardianship or legal protection
- Patient unable to express non-opposition
- Patient unreachable after 4 attempted calls over 3 consecutive weeks
- Patient deceased at the time of the telephone call
- Persons deprived of their liberty by a judicial or administrative decision
- Persons under compulsory psychiatric care
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gériatrie aigue, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69003
About this study
Official title: Pilot Study of Geriatric Parameters and Quality of Life in Patients Over 70 Years Old Undergoing Pancreatic Cancer Surgery
Pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. In France, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men.
Surgery is currently the only curative option available to patients, but it is not an option for many patients who already have metastatic or locally advanced cancer at the time of diagnosis. The main studies carried out on this type of intervention in the elderly focus on the surgical aspect, and the tolerability of such surgery is not well studied.
Read more
The aim of this study is to describe the impact of pancreatic surgery on the independence in daily activities and quality of life of patients aged over 70 with pancreatic cancer. These patients underwent surgery at Édouard Herriot Hospital (Hospices Civils de Lyon) since July 2021, and the assessment will be conducted through telephone questionnaires.
It is hypothesised that these patients will be able to maintain their independence in terms of daily activities.
- Conditions
- Pancreatic Cancer, Surgery, Elderly
- Being tested
- Phone call
- Keywords
- Pancreatic cancer, pancreatectomy, pancreatic surgery, independence, quality of life, elderly people, octogenarian, geriatric assessment
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callOther
The only follow-up visit provided for in the protocol was a telephone contact 3 to 30 months after the patient's surgery. The rest of the data required for the study were obtained from the patient's medical records, collected in the course of routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Patients over 70 undergoing pancreatic cancer surgery at the Édouard Herriot Hospital. | This is a non-comparative study, in which all subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen, operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the Édouard Herriot Hospital since July 2021, aged 70 or older at the time of surgery, will be included in the same group. Receives: Other: Phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution in the ADL questionnaire score between pre-operative and post-operative 3 to 30 months after surgery.
The ADL score (Activities of Daily Living) is designed to assess independence for activities of daily living. It is scored from 0 to 6, with 6 representing maximum independence for activities of daily living (washing, eating, dressing, etc.) and 0 a complete lack of independence.
The significance of the difference in the ADL score before and after surgery will be tested using the Wilcoxon test.
ADL will therefore be measured at 3 months after surgery at the earliest and at 30 months at the latest, at the time of the telephone call with the patient. The pre-operative value is recorded in the patient's file, measured a few weeks before surgery.
Measured: Between 3 months and 30 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start6 Nov 2023
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byeul-A KIM, MD, Principal investigator, Service de Gériatrie aigue, Hôpital Édouard Herriot, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079229
- Sponsor's protocol ID
- 69HCL23_0569
- Other IDs
- 2023-A01551-44
- Acronym
- ADL_DPC_PA
- Status last verified
- May 2024
- First submitted
- 6 Oct 2023
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Geriatric Parameters and Quality of Life in Patients Over 70 Years Old Undergoing Pancreatic Cancer Surgery
- ClinicalTrials.gov ID
- NCT06079229
- Acronym / sponsor ID
- ADL_DPC_PA / 69HCL23_0569
- Conditions
- Pancreatic Cancer, Surgery, Elderly
- Keywords
- Pancreatic cancer, pancreatectomy, pancreatic surgery, independence, quality of life, elderly people, octogenarian, geriatric assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 12 Oct 2023 (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.
Pancreatic cancer mainly affects the elderly, with over 85% of patients diagnosed after the age of 60 and over half after the age of 70. In France, the incidence of pancreatic cancer is currently around 14,000 new cases per year, making it the fourth leading cause of cancer death in women and the fifth in men.
Surgery is currently the only curative option available to patients, but it is not an option for many patients who already have metastatic or locally advanced cancer at the time of diagnosis. The main studies carried out on this type of intervention in the elderly focus on the surgical aspect, and the tolerability of such surgery is not well studied.
The aim of this study is to describe the impact of pancreatic surgery on the independence in daily activities and quality of life of patients aged over 70 with pancreatic cancer. These patients underwent surgery at Édouard Herriot Hospital (Hospices Civils de Lyon) since July 2021, and the assessment will be conducted through telephone questionnaires.
It is hypothesised that these patients will be able to maintain their independence in terms of daily activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients over 70 undergoing pancreatic cancer surgery at the Édouard Herriot Hospital. | – | Other: Phone callThis is a non-comparative study, in which all subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen, operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the Édouard Herriot Hospital since July 2021, aged 70 or older at the time of surgery, will be included in the same group. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study focuses on adult patients over the age of 70 with pancreatic cancer (of any type) who have undergone pancreatectomy and have been operated on at the Édouard Herriot Hospital, Lyon, France since July 2021.
Key inclusion criteria (3 listed)
- Subjects with histologically proven pancreatic cancer (all types) on biopsy or surgical specimen
- Operated on for this cancer (by cephalic duodenopancreatectomy or left pancreatectomy) at the Édouard Herriot Hospital since July 2021
- 70 years of age or older at the time of surgery.
Key exclusion criteria (7 listed)
- Patients who have expressed their opposition to the study
- Patients under curatorship, guardianship or legal protection
- Patient unable to express non-opposition
- Patient unreachable after 4 attempted calls over 3 consecutive weeks
- Patient deceased at the time of the telephone call
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callThe only follow-up visit provided for in the protocol was a telephone contact 3 to 30 months after the patient's surgery. The rest of the data required for the study were obtained from the patient's medical records, collected in the course of routine practice. | Other | Patients over 70 undergoing pancreatic cancer surgery at the Édouard Herriot Hospital. |
Primary outcome
Evolution in the ADL questionnaire score between pre-operative and post-operative 3 to 30 months after surgery.
Time frame: Between 3 months and 30 months after surgery.
The ADL score (Activities of Daily Living) is designed to assess independence for activities of daily living. It is scored from 0 to 6, with 6 representing maximum independence for activities of daily living (washing, eating, dressing, etc.) and 0 a complete lack of independence. The significance of the difference in the ADL score before and after surgery will be tested using the Wilcoxon test. ADL will therefore be measured at 3 months after surgery at the earliest and at 30 months at the latest, at the time of the telephone call with the patient. The pre-operative value is recorded in the patient's file, measured a few weeks before surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Byeul-A KIM, MD principal investigator
Service de Gériatrie aigue, Hôpital Édouard Herriot, Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Surgery, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 7 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 28 May 2024. 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 France. 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?
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?
Evolution in the ADL questionnaire score between pre-operative and post-operative 3 to 30 months after surgery. (time frame: Between 3 months and 30 months after surgery.). 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 28 May 2024.