CancerDPCMGNCT04395040
Identify the Obstacles to Early Diagnosis of Cancer in Patients Over 75 Years Old, on an Outpatient Basis
An observational study of Cancer and Aging, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
A third of cancers are diagnosed in patients over 75 years of age. There are fears of the elderly talking about new symptoms. The doctor may find himself trapped by general symptoms, which can be confused with "normal aging". Read more about this study
- Who is it for?
- Ages 75 years and older
- What is being tested?
- Semi-structured interview
- How many people
- 16 participants
- Where
- 3 sitesFrance
- Study dates
- 8 May 2020to 2 Oct 2020
- 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 75 years and older
- All sexes
- Older adult
Study population: Elderly patients with digestive or breast cancer.
Who may be able to join
- Patients over 75 years old (terminal included)
- Incident diagnosis
- Has cancer whose diagnosis dates back more than 3 months
- Digestive cancer, breast cancer
- Stage of advanced cancer (TNM stage: T> T2 (terminal included), M1)
- According to the opinion of the oncogeriatrician on the time of taking charge
Show all 9Show fewer
- Follow-up of a geriatrics service, onco-geriatrics orientation
- Living in the Rhône department
- Non-opposition of the patient to the study
Who cannot join
- Cancer diagnosis more than 6 months old
- Patient denies
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Léon Bérard
Lyon
Hôpital Lyon Sud
Pierre-Bénite
Centre hospitalier Fleyriat
Viriat, 01440
About this study
A third of cancers are diagnosed in patients over 75 years of age. There are fears of the elderly talking about new symptoms. The doctor may find himself trapped by general symptoms, which can be confused with "normal aging".
Some older, younger people have lived in a world where cancer was little talked about, where there was little treatment possible.
Read more
There is an idea that doctors are not very quick to start curative treatment because they think that the elderly cannot bear it.
It is important to differentiate screening and early diagnosis.
Delayed treatment causes a decrease in survival and quality of life. Cancer can be discovered suddenly: for example, occlusion with peritonitis in case of a stenosing colonic tumor, leading to urgent management.
The elderly are often excluded from clinical studies.
In addition, the geriatric population is heterogeneous, leading to very diverse and individual care, with prioritization of issues.
Oncogeriatrics, which combines two services (oncology and geriatrics), is a specialized discipline, promoting comprehensive care for the elderly patient with cancer.
The general practitioner is at the center of care. It detects early signs and starts examinations if necessary.
Cancer care can be divided up with the different stages of care with various teams, including organ specialists.
The general practitioner is the privileged interlocutor for the patient and their family (medico-psycho-social plan), who knows their history and their experience.
- Being tested
- Semi-structured interview
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
Semi-structured interview
| Study group | Role | What they receive |
|---|---|---|
| Patients | Elderly patients with digestive cancer or breast cancer. Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the obstacles to the early diagnosis of cancer in patients over 75 years old suffering from cancer.
Explore, during a semi-structured interview with the patient, the brakes and levers:
- related to the patient
- linked to the doctor: felt on the practices of health professionals, paternalistic, patient-centered approach
- linked to the disease: symptoms, acceptance of examinations, acceptance of diagnosis
- linked to society
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start8 May 2020
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille TAZELMATI, MD Student, Principal investigator, Hospices Civils de LyonMarie VALERO, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395040
- Sponsor's protocol ID
- 69HCL19_0731
- Acronym
- DPCMG
- Status last verified
- Jun 2021
- First submitted
- 15 May 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify the Obstacles to Early Diagnosis of Cancer in Patients Over 75 Years Old, on an Outpatient Basis
- ClinicalTrials.gov ID
- NCT04395040
- Acronym / sponsor ID
- DPCMG / 69HCL19_0731
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 May 2020 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 20 May 2020 (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.
A third of cancers are diagnosed in patients over 75 years of age. There are fears of the elderly talking about new symptoms. The doctor may find himself trapped by general symptoms, which can be confused with "normal aging".
Some older, younger people have lived in a world where cancer was little talked about, where there was little treatment possible.
There is an idea that doctors are not very quick to start curative treatment because they think that the elderly cannot bear it.
It is important to differentiate screening and early diagnosis.
Delayed treatment causes a decrease in survival and quality of life. Cancer can be discovered suddenly: for example, occlusion with peritonitis in case of a stenosing colonic tumor, leading to urgent management.
The elderly are often excluded from clinical studies.
In addition, the geriatric population is heterogeneous, leading to very diverse and individual care, with prioritization of issues.
Oncogeriatrics, which combines two services (oncology and geriatrics), is a specialized discipline, promoting comprehensive care for the elderly patient with cancer.
The general practitioner is at the center of care. It detects early signs and starts examinations if necessary.
Cancer care can be divided up with the different stages of care with various teams, including organ specialists.
The general practitioner is the privileged interlocutor for the patient and their family (medico-psycho-social plan), who knows their history and their experience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Semi-structured interviewElderly patients with digestive cancer or breast cancer. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly patients with digestive or breast cancer.
Key inclusion criteria (9 listed)
- Patients over 75 years old (terminal included)
- Incident diagnosis
- Has cancer whose diagnosis dates back more than 3 months
- Digestive cancer, breast cancer
- Stage of advanced cancer (TNM stage: T> T2 (terminal included), M1)
Key exclusion criteria (2 listed)
- Cancer diagnosis more than 6 months old
- Patient denies
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 |
|---|---|---|
| Semi-structured interviewSemi-structured interview | Other | Patients |
Primary outcome
Identify the obstacles to the early diagnosis of cancer in patients over 75 years old suffering from cancer.
Time frame: 1 hour
Explore, during a semi-structured interview with the patient, the brakes and levers: * related to the patient * linked to the doctor: felt on the practices of health professionals, paternalistic, patient-centered approach * linked to the disease: symptoms, acceptance of examinations, acceptance of diagnosis * linked to society
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 21 Jun 2021.
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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.
Camille TAZELMATI, MD Student principal investigator
Hospices Civils de Lyon
Marie VALERO, MD study director
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Aging, run by Hospices Civils de Lyon at 3 sites 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 9 inclusion and 2 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 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Identify the obstacles to the early diagnosis of cancer in patients over 75 years old suffering from cancer. (time frame: 1 hour). 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 21 Jun 2021.