AnemiaSPECTRO-HbNCT07701499
Validation of Non-Invasive Hemoglobin Measurement Using Optical Method for Anemia Screening Among Adults in Jakarta
An observational study of Anemia, run by Tarumanagara University at 1 site in Indonesia.
Trial summary
Anemia remains a major public health concern and is commonly diagnosed through hemoglobin measurement using capillary or venous blood samples. Although laboratory-based and point-of-care testing methods are widely used, they require blood collection, trained personnel, and may cause discomfort to participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Jul 2026to 30 Jul 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18 years and older participating in community-based health screening activities in Jakarta. Participants include both healthy individuals and individuals with potential anemia or other underlying medical conditions. All participants undergo non-invasive hemoglobin measurement, capillary hemoglobin testing using POCT, and venous blood hemoglobin measurement using an automated hematology analyzer during a single study visit.
Who may be able to join
- Adults aged 18 years and older.
- Residents or community members participating in community health screening activities in Kelurahan Kota Bambu, Jakarta.
- Willing to undergo non-invasive hemoglobin measurement.
- Willing to undergo capillary blood hemoglobin testing using point-of-care testing (POCT).
- Willing to undergo venous blood collection for hematology analyzer examination.
- Able to provide written informed consent.
Who cannot join
- Active bleeding at the time of examination.
- Severe acute illness requiring urgent medical attention.
- Refusal to undergo finger-prick or venous blood sampling.
- History of severe anxiety, syncope, or adverse reactions related to blood collection procedures.
- Visible infection, wound, or skin lesion at the measurement site.
- Severe hand deformity preventing proper non-invasive measurement.
Show all 9Show fewer
- Nail polish or artificial nails that cannot be removed before examination.
- Markedly cold hands or poor peripheral perfusion that may interfere with optical measurements.
- Incomplete hemoglobin measurement data from any of the study methods.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ernawati Ernawati, Dr contact
Indonesia1 site
Kota Bambu Subdistrict
Jakarta, DKI Jakarta, 11420
Yohanes Firmansyah, 081297934375, yohanes@fk.untar.ac.id
Ernawati Ernawati, Dr, ernawati@fk.untar.ac.id
About this study
Official title: Validation of Non-Invasive Hemoglobin Measurement (Using Optical Method) Compared With Point-of-Care Testing and Hematology Analyzer Among Adult in Jakarta
Anemia remains a major public health concern and is commonly diagnosed through hemoglobin measurement using capillary or venous blood samples. Although laboratory-based and point-of-care testing methods are widely used, they require blood collection, trained personnel, and may cause discomfort to participants. Non-invasive spectrophotometric technology has emerged as a potential alternative for rapid hemoglobin assessment without blood sampling.
This study aims to evaluate the validity and diagnostic performance of a non-invasive hemoglobin using optical method compared with capillary point-of-care testing (POCT) and venous blood hemoglobin measured using an automated hematology analyzer as the reference standard. A total of 150 adults from Kelurahan Kota Bambu, Jakarta, will undergo non-invasive hemoglobin measurement, capillary blood testing, and venous blood testing during a single study visit.
The study will assess agreement between methods, diagnostic accuracy for anemia detection, and factors that may influence measurement performance. Findings from this study are expected to support the development of convenient, community-based anemia screening strategies and provide evidence for future implementation of non-invasive hemoglobin assessment technologies.
Read the detailed description
Background
Anemia affects billions of people worldwide and remains an important public health challenge, particularly in low- and middle-income countries. Undiagnosed anemia is associated with impaired physical performance, reduced productivity, cognitive dysfunction, poor maternal outcomes, and increased morbidity. Early detection of anemia is therefore essential for timely intervention and prevention of complications.
Conventional hemoglobin measurement relies on venous blood analysis using automated hematology analyzers or capillary blood testing using point-of-care devices. While these methods provide reliable results, they require blood collection, trained healthcare personnel, consumable materials, and appropriate laboratory infrastructure. In addition, invasive sampling may cause pain, anxiety, and reluctance to participate in large-scale screening programs.
Recent advances in optical and spectrophotometric technologies have enabled the development of non-invasive methods for estimating hemoglobin concentration without blood collection. These systems utilize light absorption and reflection characteristics of peripheral tissues to estimate hemoglobin levels rapidly and painlessly. Non-invasive approaches may improve participant acceptance, facilitate repeated measurements, and support large-scale community screening initiatives. However, their accuracy and agreement with established laboratory methods remain variable across populations and settings. Therefore, local validation studies are necessary before widespread implementation.
Objectives
Primary Objective
To evaluate the validity and agreement of a non-invasive hemoglobin measurement method compared with capillary POCT hemoglobin measurement and venous blood hemoglobin measured using an automated hematology analyzer.
Secondary Objectives
To determine the correlation between non-invasive hemoglobin measurements and hematology analyzer results.
To assess agreement between non-invasive measurements, POCT results, and hematology analyzer measurements using Bland-Altman analysis.
To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios, and diagnostic accuracy for anemia detection.
To explore the feasibility of implementing non-invasive hemoglobin measurement in community-based screening programs.
Study Design
This study is a community-based cross-sectional diagnostic validation study.
Study Population
The study population consists of adults aged 18 years and older participating in community health screening activities in Kelurahan Kota Bambu, Jakarta.
Sample Size
A total of 150 participants will be recruited using consecutive sampling. Sample size calculation was based on an expected diagnostic accuracy of 90%, a confidence level of 95%, and a margin of error of 5%, with additional participants included to compensate for incomplete data.
Study Procedures
Each participant will undergo three hemoglobin measurements during a single study visit:
Non-Invasive Hemoglobin Measurement Performed on the thumb using a using optical method device. No blood collection is required. Capillary Hemoglobin Measurement Obtained through finger-prick blood sampling. Measured using a point-of-care testing (POCT) device. Venous Hemoglobin Measurement Venous blood collected by trained healthcare personnel. Analyzed using an automated hematology analyzer as the reference standard.
Demographic information, medical history, smoking status, anthropometric measurements, and factors potentially affecting measurement accuracy will also be collected.
Outcome Measures
Primary Outcome
Agreement between non-invasive hemoglobin measurements and venous hemoglobin measured using a hematology analyzer.
Secondary Outcomes
Correlation coefficients between methods. Mean measurement bias and limits of agreement. Sensitivity and specificity for anemia detection. Positive and negative predictive values. Likelihood ratios. Area under the receiver operating characteristic (ROC) curve. Cohen's kappa coefficient for anemia classification agreement. Statistical Analysis
Descriptive statistics will summarize participant characteristics and hemoglobin measurements. Agreement between methods will be assessed using Bland-Altman analysis and Intraclass Correlation Coefficients (ICC). Correlation analyses will be conducted using Pearson or Spearman tests as appropriate. Diagnostic performance will be evaluated through sensitivity, specificity, predictive values, likelihood ratios, ROC analysis, and area under the curve (AUC). Cohen's kappa coefficient will assess agreement in anemia classification. Subgroup analyses may be performed according to age, sex, and measurement conditions.
Expected Impact
The study is expected to provide evidence regarding the accuracy and screening capability of non-invasive hemoglobin measurement in community settings. Results may contribute to the development of accessible, rapid, and patient-friendly anemia screening programs and support future research involving pediatric and other vulnerable populations.
- Conditions
- Anemia
- Keywords
- Anemia, Hemoglobin, Point-of-Care Testing, Hematology Analyzer, Diagnostic Validation', Diagnostic Accuracy, Anemia Screening, Community Screening, Optical Hemoglobin Measurement, Non-Invasive Hemoglobin Measurement, optical method
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Validation Cohort | A cohort of 200 adults recruited from community screening activities. Each participant undergoes three hemoglobin assessments: non-invasive hemoglobin measurement, capillary blood hemoglobin measurement using POCT, and venous blood hemoglobin measurement using an automated hematology analyzer as the reference standard. Data are used to evaluate agreement, diagnostic accuracy, and anemia classification performance of the non-invasive measurement method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
Assessment of agreement between non-invasive hemoglobin values and venous hemoglobin values measured using an automated hematology analyzer using Bland-Altman analysis, mean bias, 95% limits of agreement, and intraclass correlation coefficient (ICC).
Measured: Day 1
Diagnostic Accuracy for Anemia Detection
Diagnostic performance of non-invasive hemoglobin measurement for identifying anemia compared with hematology analyzer results, including sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy.
Measured: Day 1
Secondary outcomes (4)
Correlation Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
Hemoglobin concentration obtained from the non-invasive device will be compared with venous hemoglobin concentration measured using a laboratory hematology analyzer. The strength and direction of the relationship will be quantified using Pearson's correlation coefficient for normally distributed data or Spearman's rank correlation coefficient for non-normally distributed data. Correlation coefficients (r), 95% confidence intervals, and p-values will be reported.
Measured: Day 1
Agreement Between Non-Invasive Hemoglobin Measurement and Point-of-Care Testing
Hemoglobin concentration obtained from the non-invasive device will be compared with capillary hemoglobin concentration measured using a point-of-care testing (POCT) device. Agreement will be evaluated using Bland-Altman analysis, including mean bias and 95% limits of agreement. Intraclass correlation coefficients (ICC) with 95% confidence intervals will also be calculated to assess measurement reliability between methods.
Measured: Day 1
Area Under the ROC Curve (AUC) for Anemia Detection
The diagnostic performance of the non-invasive hemoglobin measurement device for identifying anemia will be evaluated using receiver operating characteristic (ROC) curve analysis, with venous hemoglobin concentration measured by a hematology analyzer serving as the reference standard. The area under the ROC curve (AUC), optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value will be reported.
Measured: Day 1
Agreement in Anemia Classification
Participants will be classified as anemic or non-anemic based on established hemoglobin thresholds. Agreement between anemia classifications derived from non-invasive hemoglobin measurements and venous hemoglobin measurements obtained using a hematology analyzer will be assessed using Cohen's kappa coefficient. Kappa values and corresponding 95% confidence intervals will be reported.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start11 Jul 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarumanagara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yohanes Firmansyah, dr, MH, MM, Tarumanagara University
- Investigators
- Alexander Halim Santoso, Study director, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701499
- Sponsor's protocol ID
- UNTAR-HB-SPECTRO-2026
- Acronym
- SPECTRO-Hb
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD Sharing Description De-identified individual participant data underlying the results reported in publications may be shared upon reasonable request to the principal investigator, following approval by the institutional ethics committee and execution of an appropriate data-sharing agreement. Supporting Information Study protocol, statistical analysis plan, and data dictionary. Time Frame Beginning 6 months after publication and ending 5 years after publication. Access Criteria Access will be granted to qualified researchers for scientifically sound research proposals, subject to ethical approval and institutional review.
Publications
Shah N, Osea EA, Martinez GJ. Accuracy of noninvasive hemoglobin and invasive point-of-care hemoglobin testing compared with a laboratory analyzer. Int J Lab Hematol. 2014 Feb;36(1):56-61. doi: 10.1111/ijlh.12118. Epub 2013 Jun 27.
PubMed 23809685Chen YY, Lai GH, Chen CT, Cheng HC, Tseng SH. Noninvasive hemoglobin quantification across different cohorts using a wearable diffuse reflectance spectroscopy system. Biomed Opt Express. 2024 Feb 20;15(3):1739-1749. doi: 10.1364/BOE.517645. eCollection 2024 Mar 1.
PubMed 38495710Alwabari M, Alhamad F, Alsahaf F, Al Amer F, Alniniya F, Alherz I, Omer N, Bushehab A, Yassen K. Can Non-Invasive Spectrophotometric Hemoglobin Replace Laboratory Hemoglobin Concentrations for Preoperative Anemia Screening? A Diagnostic Test Accuracy Study. J Clin Med. 2023 Sep 3;12(17):5733. doi: 10.3390/jcm12175733.
PubMed 37685800
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Non-Invasive Hemoglobin Measurement (Using Optical Method) Compared With Point-of-Care Testing and Hematology Analyzer Among Adult in Jakarta
- ClinicalTrials.gov ID
- NCT07701499
- Acronym / sponsor ID
- SPECTRO-Hb / UNTAR-HB-SPECTRO-2026
- Conditions
- Anemia
- Keywords
- Anemia, Hemoglobin, Point-of-Care Testing, Hematology Analyzer, Diagnostic Validation', Diagnostic Accuracy, Anemia Screening, Community Screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tarumanagara UniversityUniversity, hospital or other
- Study start
- 11 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 14 Jul 2026 (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.
Anemia remains a major public health concern and is commonly diagnosed through hemoglobin measurement using capillary or venous blood samples. Although laboratory-based and point-of-care testing methods are widely used, they require blood collection, trained personnel, and may cause discomfort to participants. Non-invasive spectrophotometric technology has emerged as a potential alternative for rapid hemoglobin assessment without blood sampling.
This study aims to evaluate the validity and diagnostic performance of a non-invasive hemoglobin using optical method compared with capillary point-of-care testing (POCT) and venous blood hemoglobin measured using an automated hematology analyzer as the reference standard. A total of 150 adults from Kelurahan Kota Bambu, Jakarta, will undergo non-invasive hemoglobin measurement, capillary blood testing, and venous blood testing during a single study visit.
The study will assess agreement between methods, diagnostic accuracy for anemia detection, and factors that may influence measurement performance. Findings from this study are expected to support the development of convenient, community-based anemia screening strategies and provide evidence for future implementation of non-invasive hemoglobin assessment technologies.
Detailed description
Background
Anemia affects billions of people worldwide and remains an important public health challenge, particularly in low- and middle-income countries. Undiagnosed anemia is associated with impaired physical performance, reduced productivity, cognitive dysfunction, poor maternal outcomes, and increased morbidity. Early detection of anemia is therefore essential for timely intervention and prevention of complications.
Conventional hemoglobin measurement relies on venous blood analysis using automated hematology analyzers or capillary blood testing using point-of-care devices. While these methods provide reliable results, they require blood collection, trained healthcare personnel, consumable materials, and appropriate laboratory infrastructure. In addition, invasive sampling may cause pain, anxiety, and reluctance to participate in large-scale screening programs.
Recent advances in optical and spectrophotometric technologies have enabled the development of non-invasive methods for estimating hemoglobin concentration without blood collection. These systems utilize light absorption and reflection characteristics of peripheral tissues to estimate hemoglobin levels rapidly and painlessly. Non-invasive approaches may improve participant acceptance, facilitate repeated measurements, and support large-scale community screening initiatives. However, their accuracy and agreement with established laboratory methods remain variable across populations and settings. Therefore, local validation studies are necessary before widespread implementation.
Objectives
Primary Objective
To evaluate the validity and agreement of a non-invasive hemoglobin measurement method compared with capillary POCT hemoglobin measurement and venous blood hemoglobin measured using an automated hematology analyzer.
Secondary Objectives
To determine the correlation between non-invasive hemoglobin measurements and hematology analyzer results.
To assess agreement between non-invasive measurements, POCT results, and hematology analyzer measurements using Bland-Altman analysis.
To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios, and diagnostic accuracy for anemia detection.
To explore the feasibility of implementing non-invasive hemoglobin measurement in community-based screening programs.
Study Design
This study is a community-based cross-sectional diagnostic validation study.
Study Population
The study population consists of adults aged 18 years and older participating in community health screening activities in Kelurahan Kota Bambu, Jakarta.
Sample Size
A total of 150 participants will be recruited using consecutive sampling. Sample size calculation was based on an expected diagnostic accuracy of 90%, a confidence level of 95%, and a margin of error of 5%, with additional participants included to compensate for incomplete data.
Study Procedures
Each participant will undergo three hemoglobin measurements during a single study visit:
Non-Invasive Hemoglobin Measurement Performed on the thumb using a using optical method device. No blood collection is required. Capillary Hemoglobin Measurement Obtained through finger-prick blood sampling. Measured using a point-of-care testing (POCT) device. Venous Hemoglobin Measurement Venous blood collected by trained healthcare personnel. Analyzed using an automated hematology analyzer as the reference standard.
Demographic information, medical history, smoking status, anthropometric measurements, and factors potentially affecting measurement accuracy will also be collected.
Outcome Measures
Primary Outcome
Agreement between non-invasive hemoglobin measurements and venous hemoglobin measured using a hematology analyzer.
Secondary Outcomes
Correlation coefficients between methods. Mean measurement bias and limits of agreement. Sensitivity and specificity for anemia detection. Positive and negative predictive values. Likelihood ratios. Area under the receiver operating characteristic (ROC) curve. Cohen's kappa coefficient for anemia classification agreement. Statistical Analysis
Descriptive statistics will summarize participant characteristics and hemoglobin measurements. Agreement between methods will be assessed using Bland-Altman analysis and Intraclass Correlation Coefficients (ICC). Correlation analyses will be conducted using Pearson or Spearman tests as appropriate. Diagnostic performance will be evaluated through sensitivity, specificity, predictive values, likelihood ratios, ROC analysis, and area under the curve (AUC). Cohen's kappa coefficient will assess agreement in anemia classification. Subgroup analyses may be performed according to age, sex, and measurement conditions.
Expected Impact
The study is expected to provide evidence regarding the accuracy and screening capability of non-invasive hemoglobin measurement in community settings. Results may contribute to the development of accessible, rapid, and patient-friendly anemia screening programs and support future research involving pediatric and other vulnerable populations.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Validation Cohort | – | –A cohort of 200 adults recruited from community screening activities. Each participant undergoes three hemoglobin assessments: non-invasive hemoglobin measurement, capillary blood hemoglobin measurement using POCT, and venous blood hemoglobin measurement using an automated hematology analyzer as the reference standard. Data are used to evaluate agreement, diagnostic accuracy, and anemia classification performance of the non-invasive measurement method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years and older participating in community-based health screening activities in Jakarta. Participants include both healthy individuals and individuals with potential anemia or other underlying medical conditions. All participants undergo non-invasive hemoglobin measurement, capillary hemoglobin testing using POCT, and venous blood hemoglobin measurement using an automated hematology analyzer during a single study visit.
Key inclusion criteria (6 listed)
- Adults aged 18 years and older.
- Residents or community members participating in community health screening activities in Kelurahan Kota Bambu, Jakarta.
- Willing to undergo non-invasive hemoglobin measurement.
- Willing to undergo capillary blood hemoglobin testing using point-of-care testing (POCT).
- Willing to undergo venous blood collection for hematology analyzer examination.
Key exclusion criteria (9 listed)
- Active bleeding at the time of examination.
- Severe acute illness requiring urgent medical attention.
- Refusal to undergo finger-prick or venous blood sampling.
- History of severe anxiety, syncope, or adverse reactions related to blood collection procedures.
- Visible infection, wound, or skin lesion at the measurement site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
Time frame: Day 1
Assessment of agreement between non-invasive hemoglobin values and venous hemoglobin values measured using an automated hematology analyzer using Bland-Altman analysis, mean bias, 95% limits of agreement, and intraclass correlation coefficient (ICC).
Diagnostic Accuracy for Anemia Detection
Time frame: Day 1
Diagnostic performance of non-invasive hemoglobin measurement for identifying anemia compared with hematology analyzer results, including sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy.
4 secondary outcomes
Correlation Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer
Time frame: Day 1
Agreement Between Non-Invasive Hemoglobin Measurement and Point-of-Care Testing
Time frame: Day 1
Area Under the ROC Curve (AUC) for Anemia Detection
Time frame: Day 1
Agreement in Anemia Classification
Time frame: Day 1
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 15 Jul 2026.
- Background: PubMed 23809685Shah N, Osea EA, Martinez GJ. Accuracy of noninvasive hemoglobin and invasive point-of-care hemoglobin testing compared with a laboratory analyzer. Int J Lab Hematol. 2014 Feb;36(1):56-61. doi: 10.1111/ijlh.12118. Epub 2013 Jun 27.
- Background: PubMed 38495710Chen YY, Lai GH, Chen CT, Cheng HC, Tseng SH. Noninvasive hemoglobin quantification across different cohorts using a wearable diffuse reflectance spectroscopy system. Biomed Opt Express. 2024 Feb 20;15(3):1739-1749. doi: 10.1364/BOE.517645. eCollection 2024 Mar 1.
- Background: PubMed 37685800Alwabari M, Alhamad F, Alsahaf F, Al Amer F, Alniniya F, Alherz I, Omer N, Bushehab A, Yassen K. Can Non-Invasive Spectrophotometric Hemoglobin Replace Laboratory Hemoglobin Concentrations for Preoperative Anemia Screening? A Diagnostic Test Accuracy Study. J Clin Med. 2023 Sep 3;12(17):5733. doi: 10.3390/jcm12175733.
- Individual participant dataSharing planned: Undecided. IPD Sharing Description De-identified individual participant data underlying the results reported in publications may be shared upon reasonable request to the principal investigator, following approval by the institutional ethics committee and execution of an appropriate data-sharing agreement. Supporting Information Study protocol, statistical analysis plan, and data dictionary. Time Frame Beginning 6 months after publication and ending 5 years after publication. Access Criteria Access will be granted to qualified researchers for scientifically sound research proposals, subject to ethical approval and institutional review.
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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.
Ernawati Ernawati, Dr contact
Alexander Halim Santoso study director
Tarumanagara University
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 Anemia, run by Tarumanagara University at 1 site in Indonesia.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 15 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 Indonesia. 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 Yohanes Firmansyah, MD (+6281297934375, yohanesfirmansyah28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Non-Invasive Hemoglobin Measurement and Hematology Analyzer (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT07701499, which also lists 3 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 15 Jul 2026.