Hematologic MalignanciesELCAPANCT02884375
Elderly CAncer Patient
An observational study of Hematologic Malignancies and Solid Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hematologic Malignancies, Solid Cancer
- What is being tested?
- Extensive GA
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients aged 70 years or older, who had diagnosis of cancer (including hematologic malignancies), and referred to a getrician for GA in participating sites
Who may be able to join
- Patient aged 70 years or older
- Diagnosed cancer at all stage
- Referred to a geriatrician for GA
- Given oral non-opposition from patient or a legally mandated person
Who cannot join
- Oral opposition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Elderly Cancer Patient: ELCAPA Cohort Survey
The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. The heterogeneity of the older population in terms of comorbidities and functional status may explain the difficulty in establishing management recommendations.
Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can evaluate patient's resource and strengths, in order to help oncologist to define the most effective treatment. The GA developed by geriatricians and recommended by the International Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health status; comorbidities; functional status; nutritional, cognitive, psychological, and social parameters; and medications. The GA uses validated geriatric scales to produce an inventory of problems, which can then serve to develop an individualized geriatric intervention plan; it may be an important step in selecting elderly patients for cancer screening and treatment.
Read more
The objectives are:
- To assess the role of GA for decision making process for older patients with cancer
- To identify geriatric and oncologic factors associated with overall survival, treatment feasibility, toxicities, morbidities
- To develop and/or validate screening tests for frailty in geriatric oncology
- To develop and validate frailty classifications
Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study that includes all patients age 70 years or older who has a diagnosis of solid cancer or hematologic malignancies in French hospitals
- Conditions
- Hematologic Malignancies, Solid Cancer
- Being tested
- Extensive GA
- Keywords
- Elderly, Cancer, Geriatric assessment, Treatment, Epidemiology
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensive GAOther
GA includes an evaluation of nine domains according to international recommendations :
- functional status (six-item Activities of Daily Living (ADL) score, Instrumental Activities of Daily Living (IADL))
- mobility (timed get-up-and-go test, one-leg standing balance test, history of fall)
- nutritional status (French National Authority of Health guidelines, weight loss body mass index (BMI), Mini Nutritional Assessment, albumin )
- cognitive status (Mini-Mental State Examination (MMSE), history of dementia, confusion)
- mood (Mini-Geriatric Depression Scale (Mini-GDS), symptoms of anxiety, depression (DSM V))
- comorbidities (CIRS G)
- polypharmacy (number of medications)
- social environment (primary caregiver, support at home, friends , family, living alone)
- urinary and/or fecal incontinence
| Study group | Role | What they receive |
|---|---|---|
| Elderly cancer patient cohort | Patients aged 70 years or older, who had diagnosis of cancer in participating sites (including hematologic malignancies), and referred to a geriatrician for geriatric assessment (GA) Receives: Other: Extensive GA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment
Measured: through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).
Secondary outcomes (3)
Chemotherapy toxicities using Common Terminology Criteria for Adverse Events
Measured: through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols).
Feasibility of the planned Chemotherapy treatment (delivery of the planned number of cycles determined based on tumor site and metastatic status)
Measured: through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).
Overall mortality
Measured: Year 1 and 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startSep 2010
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Oncogeriatric Coordination Unit (UCOG) - Sud-Val-de-Marne, Oncogeriatric Coordination Unit (UCOG) - Paris-Ouest, Cancéropôle Ile De France
- Responsible party
- Sponsor
- Investigators
- PHILIPPE CAILLET, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisELENA PAILLAUD, MD-PhD, Study director, Assistance Publique - Hôpitaux de ParisFLORENCE CANOUI-POITRINE, MD-PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884375
- Sponsor's protocol ID
- UG 6729 UCOG
- Acronym
- ELCAPA
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Couderc AL, Martinez-Tapia C, Mathoulin-Pelissier S, Laurent M, Bringuier M, Gay P, Caillet P, Bertona J, Greillier L, Canovas J, Soubeyran P, Rostoft S, Canoui-Poitrine F, Paillaud E. Using the Geriatric Core Dataset (G-CODE) to predict mortality in older patients with cancer: development and external validation. Br J Cancer. 2026 Oct 12. doi: 10.1038/s41416-026-03641-5. Online ahead of print.
PubMed 42864377de Salins V, Martinez-Tapia C, Gay P, Morel A, Bringuier M, Boudou-Rouquette P, Corsin L, Aregui A, Canovas J, Rautou PE, Soubeyran P, Bellera C, Canoui-Poitrine F, Paillaud E, Poisson J. The Fibrosis-4 score is associated with overall mortality and severe haematological toxicity in older patients with cancer: Analysis of two prospective cohort studies. Int J Cancer. 2025 Dec 15;157(12):2506-2520. doi: 10.1002/ijc.70071. Epub 2025 Aug 6.
PubMed 40767026Frasca M, Martinez-Tapia C, Jean C, Chanteclair A, Galvin A, Bergua V, Hagege M, Caillet P, Laurent M, Brain E, Mathoulin-Pelissier S, Paillaud E, Canoui-Poitrine F. Serious Health-Related Suffering Impairs Treatments and Survival in Older Patients With Cancer. J Pain Symptom Manage. 2024 Nov;68(5):506-515.e5. doi: 10.1016/j.jpainsymman.2024.08.002. Epub 2024 Aug 13.
PubMed 39142494Gonzalez Serrano A, Laurent M, Barnay T, Martinez-Tapia C, Audureau E, Boudou-Rouquette P, Aparicio T, Rollot-Trad F, Soubeyran P, Bellera C, Caillet P, Paillaud E, Canoui-Poitrine F. A Two-Step Frailty Assessment Strategy in Older Patients With Solid Tumors: A Decision Curve Analysis. J Clin Oncol. 2023 Feb 1;41(4):826-834. doi: 10.1200/JCO.22.01118. Epub 2022 Oct 28.
PubMed 36306481Martinez-Tapia C, Diot T, Oubaya N, Paillaud E, Poisson J, Gisselbrecht M, Morisset L, Caillet P, Baudin A, Pamoukdjian F, Broussier A, Bastuji-Garin S, Laurent M, Canoui-Poitrine F. The obesity paradox for mid- and long-term mortality in older cancer patients: a prospective multicenter cohort study. Am J Clin Nutr. 2021 Jan;113(1):129-141. doi: 10.1093/ajcn/nqaa238. Epub 2020 Sep 5.
PubMed 32889525
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elderly Cancer Patient: ELCAPA Cohort Survey
- ClinicalTrials.gov ID
- NCT02884375
- Acronym / sponsor ID
- ELCAPA / UG 6729 UCOG
- Conditions
- Hematologic Malignancies, Solid Cancer
- Keywords
- Elderly, Cancer, Geriatric assessment, Treatment, Epidemiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Oncogeriatric Coordination Unit (UCOG) - Sud-Val-de-Marne, Oncogeriatric Coordination Unit (UCOG) - Paris-Ouest, Cancéropôle Ile De France
- Study start
- Sep 2010
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- 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.
The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. The heterogeneity of the older population in terms of comorbidities and functional status may explain the difficulty in establishing management recommendations.
Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can evaluate patient's resource and strengths, in order to help oncologist to define the most effective treatment. The GA developed by geriatricians and recommended by the International Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health status; comorbidities; functional status; nutritional, cognitive, psychological, and social parameters; and medications. The GA uses validated geriatric scales to produce an inventory of problems, which can then serve to develop an individualized geriatric intervention plan; it may be an important step in selecting elderly patients for cancer screening and treatment.
The objectives are:
- To assess the role of GA for decision making process for older patients with cancer
- To identify geriatric and oncologic factors associated with overall survival, treatment feasibility, toxicities, morbidities
- To develop and/or validate screening tests for frailty in geriatric oncology
- To develop and validate frailty classifications
Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study that includes all patients age 70 years or older who has a diagnosis of solid cancer or hematologic malignancies in French hospitals
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly cancer patient cohort | – | Other: Extensive GAPatients aged 70 years or older, who had diagnosis of cancer in participating sites (including hematologic malignancies), and referred to a geriatrician for geriatric assessment (GA) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients aged 70 years or older, who had diagnosis of cancer (including hematologic malignancies), and referred to a getrician for GA in participating sites
Key inclusion criteria (4 listed)
- Patient aged 70 years or older
- Diagnosed cancer at all stage
- Referred to a geriatrician for GA
- Given oral non-opposition from patient or a legally mandated person
Key exclusion criteria (1 listed)
- Oral opposition
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 |
|---|---|---|
| Extensive GAGA includes an evaluation of nine domains according to international recommendations : * functional status (six-item Activities of Daily Living (ADL) score, Instrumental Activities of Daily Living (IADL)) * mobility (timed get-up-and-go test, one-leg standing balance test, history of fall) * nutritional status (French National Authority of Health guidelines, weight loss body mass index (BMI), Mini Nutritional Assessment, albumin ) * cognitive status (Mini-Mental State Examination (MMSE), history of dementia, confusion) * mood (Mini-Geriatric Depression Scale (Mini-GDS), symptoms of anxiety, depression (DSM V)) * comorbidities (CIRS G) * polypharmacy (number of medications) * social environment (primary caregiver, support at home, friends , family, living alone) * urinary and/or fecal incontinence | Other | Elderly cancer patient cohort |
Primary outcome
Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment
Time frame: through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).
3 secondary outcomes
Chemotherapy toxicities using Common Terminology Criteria for Adverse Events
Time frame: through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative or palliative and chemotherapy protocols).
Feasibility of the planned Chemotherapy treatment (delivery of the planned number of cycles determined based on tumor site and metastatic status)
Time frame: through chemotherapy treatment completion, an average of 6-months after inclusion (+/- 3 months) (according to curative ou palliative and chemotherapy protocols).
Overall mortality
Time frame: Year 1 and 5 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Derived from this study: PubMed 42864377Couderc AL, Martinez-Tapia C, Mathoulin-Pelissier S, Laurent M, Bringuier M, Gay P, Caillet P, Bertona J, Greillier L, Canovas J, Soubeyran P, Rostoft S, Canoui-Poitrine F, Paillaud E. Using the Geriatric Core Dataset (G-CODE) to predict mortality in older patients with cancer: development and external validation. Br J Cancer. 2026 Oct 12. doi: 10.1038/s41416-026-03641-5. Online ahead of print.
- Derived from this study: PubMed 40767026de Salins V, Martinez-Tapia C, Gay P, Morel A, Bringuier M, Boudou-Rouquette P, Corsin L, Aregui A, Canovas J, Rautou PE, Soubeyran P, Bellera C, Canoui-Poitrine F, Paillaud E, Poisson J. The Fibrosis-4 score is associated with overall mortality and severe haematological toxicity in older patients with cancer: Analysis of two prospective cohort studies. Int J Cancer. 2025 Dec 15;157(12):2506-2520. doi: 10.1002/ijc.70071. Epub 2025 Aug 6.
- Derived from this study: PubMed 39142494Frasca M, Martinez-Tapia C, Jean C, Chanteclair A, Galvin A, Bergua V, Hagege M, Caillet P, Laurent M, Brain E, Mathoulin-Pelissier S, Paillaud E, Canoui-Poitrine F. Serious Health-Related Suffering Impairs Treatments and Survival in Older Patients With Cancer. J Pain Symptom Manage. 2024 Nov;68(5):506-515.e5. doi: 10.1016/j.jpainsymman.2024.08.002. Epub 2024 Aug 13.
- Derived from this study: PubMed 36306481Gonzalez Serrano A, Laurent M, Barnay T, Martinez-Tapia C, Audureau E, Boudou-Rouquette P, Aparicio T, Rollot-Trad F, Soubeyran P, Bellera C, Caillet P, Paillaud E, Canoui-Poitrine F. A Two-Step Frailty Assessment Strategy in Older Patients With Solid Tumors: A Decision Curve Analysis. J Clin Oncol. 2023 Feb 1;41(4):826-834. doi: 10.1200/JCO.22.01118. Epub 2022 Oct 28.
- Derived from this study: PubMed 32889525Martinez-Tapia C, Diot T, Oubaya N, Paillaud E, Poisson J, Gisselbrecht M, Morisset L, Caillet P, Baudin A, Pamoukdjian F, Broussier A, Bastuji-Garin S, Laurent M, Canoui-Poitrine F. The obesity paradox for mid- and long-term mortality in older cancer patients: a prospective multicenter cohort study. Am J Clin Nutr. 2021 Jan;113(1):129-141. doi: 10.1093/ajcn/nqaa238. Epub 2020 Sep 5.
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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.
PHILIPPE CAILLET, MD principal investigator
Assistance Publique - Hôpitaux de Paris
ELENA PAILLAUD, MD-PhD study director
Assistance Publique - Hôpitaux de Paris
FLORENCE CANOUI-POITRINE, MD-PhD study director
Assistance Publique - Hôpitaux de Paris
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 Hematologic Malignancies and Solid Cancer, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 31 Aug 2016. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PHILIPPE CAILLET, MD ((0)149814707 ext. +33, philippe.caillet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between initial oncologist treatment proposal and final treatment selected after geriatric assessment (time frame: through multidisciplinary meeting decision, an average of 2 weeks after GA (+/-1 week).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02884375, which also lists 5 linked publications.
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 31 Aug 2016.