Metastatic CancerNCT06693687
A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer
A study testing Metastatic Cancer in people with Metastatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with cancer using ApricityCare. Investigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Metastatic Cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to 1 Nov 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age or older
- Confirmed diagnosis of cancer
- Part 1 (Run-in Phase): Only patients with prostate, kidney, and/or bladder cancer will be enrolled with either localized or metastatic disease.
- Part 2 (Expansion Phase): Metastatic patients will be enrolled. Note, evaluable metastatic patients from Ppart 1 will be counted in Cohort A as described in section 8.4.
- Planned to receive systemic anti-cancer therapy
- Ability to understand and the willingness to sign a written informed consent document
- Ability to speak, read, and understand one of the following languages: English, Spanish, Mandarin and Cantonese Chinese
- Ownership of a smartphone and willingness to use it as outlined by the protocol and described in the ICF
Who cannot join
- Have any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study (pregnancy is not exclusionary and pregnant women will be permitted to enroll in the study).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Bilal A Siddiqui, MD, 713-563-4600, basiddiqui@mdanderson.org
About this study
To evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with cancer using ApricityCare.
Investigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.
Read the detailed description
Primary Objective • To determine the rate of therapy discontinuation due to toxicity among patients using ApricityCare.
Secondary Objectives
- To evaluate time the ease and experience of patient use of ApricityCare (i.e., patient engagement) in reporting symptoms during their systemic cancer treatments. Furthermore, the frequency of patient symptom reporting via check-in to ApricityCare will be evaluated, as will the time taken to respond and engage patients after they report toxicity or other adverse events via ApricityCare.
- Conditions
- Metastatic Cancer
- Being tested
- Metastatic Cancer
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metastatic CancerBehavioural
Participants will be asked to to take part in a research study because you have metastatic cancer (meaning that your cancer has spread to other parts of the body) and will be starting systemic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Cancer | Other | Participants will have 24/7 access to the ApricityCare service. Participants can check in and report any symptoms or side effects through the ApricityCare app, or by phone, at any time.
Participants will be asked to report your status at least weekly, even if participants are not experiencing any side effects. ApricityCare nurses will review each participants report and provide appropriate education and/or virtual management or escalate, as needed, to the study doctor or emergency service, based on guidelines. Each encounter with an ApricityCare nurse will be sent to the electronic health record (EHR) in real time for review/inclusion into your medical record.
For any in-person visits participants attend, the study doctor will review the ApricityCare symptom summary with participants. For all these visits, please bring your smartphone, which carries the ApricityCare application, for this review. Receives: Behavioral: Metastatic Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start18 Dec 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693687
- Sponsor's protocol ID
- 2024-0229
- Other IDs
- NCI-2024-09566
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2024
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the ApricityCare Program for Early Detection and Management of Treatment-Related Adverse Events in Patients With Cancer
- ClinicalTrials.gov ID
- NCT06693687
- Acronym / sponsor ID
- 2024-0229
- Conditions
- Metastatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 Nov 2024 (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.
To evaluate the rate of therapy discontinuation due to toxicity (side effects) among participants with cancer using ApricityCare.
Investigators want to learn if identification of early clinical signs of irAEs with timely treatment can prevent severity progression and reduce treatment discontinuation.
Detailed description
Primary Objective • To determine the rate of therapy discontinuation due to toxicity among patients using ApricityCare.
Secondary Objectives
- To evaluate time the ease and experience of patient use of ApricityCare (i.e., patient engagement) in reporting symptoms during their systemic cancer treatments. Furthermore, the frequency of patient symptom reporting via check-in to ApricityCare will be evaluated, as will the time taken to respond and engage patients after they report toxicity or other adverse events via ApricityCare.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Cancer | Other | Behavioral: Metastatic CancerParticipants will have 24/7 access to the ApricityCare service. Participants can check in and report any symptoms or side effects through the ApricityCare app, or by phone, at any time. Participants will be asked to report your status at least weekly, even if participants are not experiencing any side effects. ApricityCare nurses will review each participants report and provide appropriate education and/or virtual management or escalate, as needed, to the study doctor or emergency service, based on guidelines. Each encounter with an ApricityCare nurse will be sent to the electronic health record (EHR) in real time for review/inclusion into your medical record. For any in-person visits participants attend, the study doctor will review the ApricityCare symptom summary with participants. For all these visits, please bring your smartphone, which carries the ApricityCare application, for this review. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years of age or older
- Confirmed diagnosis of cancer
- Planned to receive systemic anti-cancer therapy
- Ability to understand and the willingness to sign a written informed consent document
- Ability to speak, read, and understand one of the following languages: English, Spanish, Mandarin and Cantonese Chinese
Key exclusion criteria (1 listed)
- Have any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study (pregnancy is not exclusionary and pregnant women will be permitted to enroll in the study).
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 |
|---|---|---|
| Metastatic CancerParticipants will be asked to to take part in a research study because you have metastatic cancer (meaning that your cancer has spread to other parts of the body) and will be starting systemic therapy. | Behavioural | Metastatic Cancer |
Primary outcome
Safety and Adverse Events
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
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 16 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metastatic Cancer in people with Metastatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 8 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 16 Jul 2026. 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 United States. 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 Bilal A Siddiqui, MD ((713) 563-4600, basiddiqui@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (time frame: Through study completion; an average of 1 year.). 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 16 Jul 2026.